Systematically Testing the Evidence on Marijuana

Carpal tunnel syndrome (CTS) is the most common nerve compression disease and the most expensive upper-extremity work-related musculoskeletal disorder, affecting approximately 10 million people in the US. To understand the clear etiology and mechanism of carpal tunnel syndrome, the measurement of median nerve intraneural blood flow needs to be further scrutinized as the common fluctuating physiological conditions and functional hand activities might contribute to the fluctuation of the measurement and serve as measurement error. This study aims to examine how intraneural blood flow within the median nerve is affected by physiological factors (i.e., body temperature and blood pressure) and functional hand activities (i.e., typing, using a mouse, and cooking).

First Posted: September 27, 2021

Condition(s): Carpal Tunnel Syndrome, Median Nerve Injury

Intervention(s): Cooling, Heating, Exercising, Typing, Using a mouse, Cooking

Status: Enrolling by invitation

Enrollment (expected or actual): 50

Allocation: N/A

Sponsor: University of Southern California

Principal Investigator: Shawn Roll, Associate Professor

Completion Date (primary or actual): December 2022

CT.gov Identifier: NCT05057754

Cortical plasticity plays a pivotal role in functional recovery after a stroke. Neurotransmitter release, facilitates the creation of new synapses and promotes brain plasticity. In a pilot study, will evaluate the potential benefit of drugs that increase the release of neurotransmitters in patients with first stroke.

First Posted: March 12, 2015

Condition(s): Stroke

Intervention(s): placebo, citalopram, sinemet plus

Status: Completed

Enrollment (expected or actual): 39

Allocation: Randomized

Sponsor: Hospital de Granollers

Principal Investigator:

Completion Date (primary or actual): March 2017

CT.gov Identifier: NCT02386475

This study is a non-interventional post-marketing observational study (PMOS) of participants with advanced Parkinson's disease (PD) treated with Duodopa/Duopa in a routine clinical setting. Effectiveness of treatment will be collected with physician and participant/caregiver health outcomes beginning with PMOS enrollment (baseline visit), at the start of Duodopa/Duopa treatment via percutaneous endoscopic gastrostomy-with jejunal extension (PEG-J), at regularly scheduled visits closest to Months 3 and 6, and every 6 months thereafter up to 36 months. An additional cohort of participants will be enrolled who in addition will be evaluated with a wearable device.

First Posted: November 23, 2015

Condition(s): Advanced Parkinson's Disease

Intervention(s):

Status: Completed

Enrollment (expected or actual): 213

Allocation:

Sponsor: AbbVie

Principal Investigator:

Completion Date (primary or actual): December 24, 2020

CT.gov Identifier: NCT02611713

The primary objective of this study was to demonstrate that Rotigotine transdermal patch is efficacious in Chinese subjects with advanced-stage Idiopathic Parkinson's Disease as an adjuvant therapy.

First Posted: July 20, 2012

Condition(s): Idiopathic Parkinson's Disease

Intervention(s): Rotigotine, Placebo Patch, L-dopa

Status: Completed

Enrollment (expected or actual): 346

Allocation: Randomized

Sponsor: UCB Pharma

Principal Investigator:

Completion Date (primary or actual): October 2014

CT.gov Identifier: NCT01646255

The purpose of this study is to assess the long term safety of SCH 420814 (preladenant) in participants with moderate to severe Parkinson's Disease who are taking an L-Dopa/dopa decarboxylase inhibitor and/or dopamine agonist. All participants must have participated in the main study (P04501; NCT00406029) entitled "A Phase 2, 12 Week, Double Blind, Dose Finding, Placebo Controlled Study to Assess the Efficacy and Safety of a Range of SCH 420814 Doses in Subjects With Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesias."

First Posted: September 28, 2007

Condition(s): Parkinson Disease, Neurodegenerative Diseases, Central Nervous System Diseases, Movement Disorders, Brain Diseases

Intervention(s): Preladenant, L-dopa, Other Parkinson's Disease treatments

Status: Completed

Enrollment (expected or actual): 140

Allocation: N/A

Sponsor: Merck Sharp & Dohme LLC

Principal Investigator:

Completion Date (primary or actual): November 19, 2009

CT.gov Identifier: NCT00537017

In an earlier study using electronic health records (EHR), the investigators have identified nine factors to be significantly associated with FA risk. These nine predictors include Furosemide intravenous 40 milligrams or more; Admissions in the past one year; Medifund status; Frequent emergency department use; Anti-depressants treatment in past one year; Charlson comorbidity index; End Stage Renal Failure on dialysis; Subsidized ward stay and Geriatric patient. The investigators have combined these nine predictors into the FAM-FACE-SG score for FA risk (defined as 3 or more inpatient admissions in the following 12 months). The FAM-FACE-SG risk score has the advantage of being deployed in our hospital's enterprise data repository known as Electronic Health Intelligence System or eHINTs for short, on a real-time or near real-time basis. On a daily basis, data from multiple data sources are extracted, transformed and loaded onto the eHINTS system. The system can be programmed to run every midnight to provide risk scores the following morning for patients admitted the previous day. In this trial, the intervention is to combine the FAM-FACE-SG risk score in addition to a decision making algorithm to guide referrals to various transitional care services based on needs assessment on nursing and function. The primary objective is to evaluate the impact of our intervention in improving healthcare utilization (hospital readmissions, emergency department (ED) attendances, length of stay up to 90 days post-discharge).

First Posted: June 28, 2016

Condition(s): Patient Readmission

Intervention(s): FAMFACESG, Control, FAMFACESG, FAMFACESG, FAMFACESG

Status: Withdrawn

Enrollment (expected or actual): 0

Allocation: Randomized

Sponsor: Singapore General Hospital

Principal Investigator:

Completion Date (primary or actual): August 2017

CT.gov Identifier: NCT02815462

This is an open-label, postmarketing, observational study to document health outcomes, in Canadian patients with advanced Parkinson's disease and long-term treatment with Duodopa (levodopa/carbidopa intestinal gel).

First Posted: June 30, 2015

Condition(s): Parkinson Disease (PD)

Intervention(s):

Status: Completed

Enrollment (expected or actual): 88

Allocation:

Sponsor: AbbVie

Principal Investigator:

Completion Date (primary or actual): February 26, 2020

CT.gov Identifier: NCT02485600

The study will be carried out in Bolu Abant İzzet Baysal University İzzet Baysal Training and Research Hospital Cardiovascular Surgery Clinic between January 2022 and February 2023. The population of the study will consist of patients who will undergo coronary artery bypass in a planned heart and meet the inclusion criteria. The sample of the study will consist of patients who meet the inclusion criteria, volunteer to participate in the study, and whose written consent has been obtained. To calculate the sample size of the study; NCSS Pass 11.0 program was used. According to the result calculated in this program, it was seen that a total of 60 people, 30 people in each group, should be reached for two groups and 99% power (α: 0.05). With this study, it is aimed to increase the job satisfaction and quality of nurses as well as to increase the satisfaction of the patients in terms of nursing. By presenting the Complementary Care Model to our country for the first time with this study; In this context, it was planned to determine the effects of music therapy, progressive muscle relaxation exercise, aromatherapy and massage on the outcomes (nausea, vomiting, sleep, anxiety, pain, complications and satisfaction) of coronary artery bypass graft patients.

First Posted: July 7, 2022

Condition(s): Nursing Caries, Music Therapy, Aromatherapy, Preoperative Care, Postoperative Care, Complementary Therapies

Intervention(s): music therapy, aromatherapy, Progressive Relaxation Exercises, Hand massage

Status: Recruiting

Enrollment (expected or actual): 60

Allocation: Randomized

Sponsor: Abant Izzet Baysal University

Principal Investigator: Ummuhan Yigid, principal investigator

Completion Date (primary or actual): November 15, 2023

CT.gov Identifier: NCT05446662

This is a Phase II trial to determine the ability of a reduced intensity conditioning regimen to allow successful engraftment with alpha/beta T and CD19+ depleted peripheral stem cell grafts from unrelated or partially matched related donors. There are two conditioning regimens depending upon patient diagnosis and age.

First Posted: December 13, 2016

Condition(s): Immunodeficiencies, Immune Dysregulation Syndromes

Intervention(s): Apha/beta T and CD19+ cell depletion using CliniMACS device

Status: Recruiting

Enrollment (expected or actual): 50

Allocation: Non-Randomized

Sponsor: Children's Hospital of Philadelphia

Principal Investigator: Nancy Bunin, Director, Blood and Marrow Transplant

Completion Date (primary or actual): December 2023

CT.gov Identifier: NCT02990819

The purpose of this study is to investigate the short-term effects of 3 approved FDA drugs (cyproheptadine (CPH), carbidopa-levodopa (CD-LD), and atomoxetine (ATX)) on motor responses when delivered in combination with hand training exercises in people with chronic spinal cord injury. The goal is to learn how to better strengthen connections between the brain and spinal cord after spinal cord injury, and if this connection is improved by one(or more) of the drugs. Multiple aspects of nerve transmission and muscle response will be measured via noninvasive brain and spinal cord stimulation, along with motor performance (dexterity and strength).

First Posted: February 1, 2023

Condition(s): Spinal Cord Injuries

Intervention(s): CPH + hand training, CD-LD + hand training, ATX + hand training, Placebo + hand training

Status: Recruiting

Enrollment (expected or actual): 28

Allocation: Randomized

Sponsor: Bronx VA Medical Center

Principal Investigator: Lynda M. Murray, Assistant Professor

Completion Date (primary or actual): July 30, 2024

CT.gov Identifier: NCT05708274

This is a data collection study that will examine the general diagnostic and treatment data associated with the reduced-intensity chemotherapy-based regimen paired with simple alemtuzumab dosing strata designed to prevented graft failure and to aid in immune reconstitution following hematopoietic stem cell transplantation.

First Posted: August 27, 2020

Condition(s): Primary Immunodeficiency (PID), Congenital Bone Marrow Failure Syndromes, Inherited Metabolic Disorders (IMD), Hereditary Anemias, Inflammatory Conditions

Intervention(s): data collection

Status: Recruiting

Enrollment (expected or actual): 50

Allocation:

Sponsor: Paul Szabolcs

Principal Investigator: Paul Szabolcs, Chief, BMT-CT at CHP of UPMC and Professor of Pediatrics and Immunology, University of Pittsburgh

Completion Date (primary or actual): December 31, 2025

CT.gov Identifier: NCT04528355

This is a Phase 3, multicenter, open-label, safety and tolerability study of continuous apomorphine infusion in subjects with advanced Parkinson's Disease (PD) whose motor fluctuations remain unsatisfactory with levodopa (or levodopa/carbidopa) and at least one other class of drugs or mode of therapy for PD.

First Posted: January 15, 2015

Condition(s): Idiopathic Parkinson's Disease

Intervention(s): apomorphine infusion

Status: Active, not recruiting

Enrollment (expected or actual): 99

Allocation: N/A

Sponsor: USWM, LLC (dba US WorldMeds)

Principal Investigator:

Completion Date (primary or actual): December 2018

CT.gov Identifier: NCT02339064

The overall objective of this protocol is to test if Gulf War Illness (GWI) involves chronic inflammation that cannot be measured with typical techniques. The investigators will be observing the effects of nine different botanical compounds (supplements) that are known to suppress inflammation. If one of those supplements helps the symptoms of GWI, it will give the investigators information about what is wrong in people with GWI.

First Posted: September 21, 2016

Condition(s): Gulf War Illness

Intervention(s): Boswellia Serrata, Curcumin, Epimedium, Fisetin, Luteolin, Nettle, Pycnogenol, Reishi Mushroom, Resveratrol, Placebo

Status: Completed

Enrollment (expected or actual): 64

Allocation: Randomized

Sponsor: University of Alabama at Birmingham

Principal Investigator: Jarred Younger, Associate Professor

Completion Date (primary or actual): September 2019

CT.gov Identifier: NCT02909686

The objective of this study is to evaluate the efficacy of using a reduced-intensity condition (RIC) regimen with umbilical cord blood transplant (UCBT), double cord UCBT, matched unrelated donor (MUD) bone marrow transplant (BMT) or peripheral blood stem cell transplant (PBSCT) in patients with non-malignant disorders that are amenable to treatment with hematopoietic stem cell transplant (HSCT). After transplant, subjects will be followed for late effects and for ongoing graft success.

First Posted: October 14, 2013

Condition(s): Primary Immunodeficiency (PID), Congenital Bone Marrow Failure Syndromes, Inherited Metabolic Disorders (IMD), Hereditary Anemias, Inflammatory Conditions

Intervention(s): Hydroxyurea, Alemtuzumab, Fludarabine, Melphalan, Thiotepa

Status: Recruiting

Enrollment (expected or actual): 100

Allocation: Non-Randomized

Sponsor: Paul Szabolcs

Principal Investigator: Paul Szabolcs, Chief, BMT-CT at CHP of UPMC and Professor of Pediatrics and Immunology, University of Pittsburgh

Completion Date (primary or actual): November 2024

CT.gov Identifier: NCT01962415

The aim of the study is to investigate the relationship between shoulder internal and external rotation isokinetic muscle strength, grip strength, anaerobic capacity, aerobic capacity and sportive performance in wheelchair basketball athletes. Through this work, we aim to contribute to the literature with objective, blood-based results. The wheelchair (WC) basketball characterizes high intensity activities such as rolling, rebounding, rolling, smashing overhead. Because these activities are fast and powerful, they require both anaerobic and aerobic capacities. The main factors affecting WC Basketball performance are upper extremity muscle strength and aerobic capacity. It is stated that higher muscle power and aerobic performance in WC Basketball will provide more independence in daily life activities as well as increased speed and power during sports play. WC basketball players have both a spore-specific activities and a shoulder rotational muscle strength aerobic power components have a critical functional role when using a wheelchair. When the literature on this subject is examined, it is seen that there is a limited number of works for WC basketball sport which is very popular nowadays. Assessment of upper limb muscle strength, aerobic capacity and sporting performance in wheelchair basketball athletes is crucial in regulating the athletes' training programs and establishing individual training programs.

First Posted: March 7, 2018

Condition(s): Sports Physical Therapy

Intervention(s): Aerobic Capacity

Status: Completed

Enrollment (expected or actual): 26

Allocation: Non-Randomized

Sponsor: Ankara Yildirim Beyazıt University

Principal Investigator:

Completion Date (primary or actual): December 30, 2017

CT.gov Identifier: NCT03455790

This phase II clinical trial studies how well treosulfan and fludarabine phosphate with or without low dose radiation before donor stem cell transplantation works in treating patients with nonmalignant (noncancerous) diseases. Hematopoietic cell transplantation has been shown to be curative for many patients with nonmalignant (noncancerous) diseases such as primary immunodeficiency disorders, bone marrow failure syndromes, hemoglobinopathies, and inborn errors of metabolism (metabolic disorders). Powerful chemotherapy drugs and/or radiation are often used to condition the patient before infusion of the new healthy donor cells. The purpose of the conditioning therapy is to destroy the patient's abnormal bone marrow which doesn't work properly in order to make way for the new healthy donor cells which functions normally. Although effective in curing the patient's disease, many hematopoietic cell transplantation regimens use intensive chemotherapy and/or radiation which can be quite toxic, have significant side effects, and can potentially be life-threatening. Investigators are investigating whether a new conditioning regimen that uses less intensive drugs (treosulfan and fludarabine phosphate) with or without low dose radiation results in new blood-forming cells (engraftment) of the new donor cells without increased toxicities in patients with nonmalignant (noncancerous) diseases.

First Posted: June 12, 2009

Condition(s): Non-Neoplastic Hematologic and Lymphocytic Disorder

Intervention(s): Allogeneic Bone Marrow Transplantation, Anti-Thymocyte Globulin, Cyclosporine, Fludarabine Phosphate, Laboratory Biomarker Analysis, Methotrexate, Mycophenolate Mofetil, Peripheral Blood Stem Cell Transplantation, Tacrolimus, Total-Body Irradiation, Treosulfan, Umbilical Cord Blood Transplantation

Status: Completed

Enrollment (expected or actual): 98

Allocation: Non-Randomized

Sponsor: Fred Hutchinson Cancer Center

Principal Investigator: Lauri Burroughs, Associate Professor, Clinical Research Division, Fred Hutch; Director, Non-Malignant Transplant Program

Completion Date (primary or actual): June 10, 2020

CT.gov Identifier: NCT00919503

Congenital bleeding disorders characterized by abnormal platelet granules include Gray Platelet syndrome (GPS; defective alpha-granules), Hermansky-Pudlak syndrome (HPS; defective delta-granules), and combined alpha delta-storage pool deficiency (alpha delta-SPD). Other diseases associated with variable defects in platelet gamma-granules include Chediak-Higashi, Griscelli, Wiskott-Aldrich, and Thrombocytopenia Absent Radius syndromes. These disorders are models for the study of organelle formation in megakaryocytes and platelets. Characteristics of megakaryocytopoiesis in these disorders have not been investigated because megakaryocytes could not be cultured from patients in sufficient quantities for experimental purposes. Recent advances have made it possible to culture megakaryocytes using serum-free media supplemented with recombinant human thrombopoietin (TPO). Such cultured human megakaryocytes, amplified from bone marrow-derived CD34+ stem cells, synthesize and store organellar proteins and produce functional platelets. In this protocol, we plan to obtain bone marrow aspirates from 40 children and adults (ages 2 to 80 years) with GPS, HPS, and related disorders. Patients admitted to the NIH Clinical Center on specific disease-related protocols will be enrolled in this protocol during their routine 3-5 day visits. We will culture megakaryocytes from CD34+ stem cells isolated from bone marrow aspirates. Studies of cultured megakaryocytes will include evaluation of granule membrane and soluble proteins using fluorescent antibodies and immunoelectron microscopy and comparison of RNA and protein expression patterns between normal and patient cells. Precautions will be taken to prevent the primary risk of the bone marrow aspiration, i.e., prolonged bleeding at the aspiration site. Standard diagnostic studies on the bone marrow sample may reveal information that may directly benefit patients. However, the broader benefit of this study is the acquisition of a better understanding of the characteristics of functional platelet disorders and the process of intracellular vesicle formation.

First Posted: July 2, 2004

Condition(s): Blood Coagulation Disorders

Intervention(s):

Status: Completed

Enrollment (expected or actual): 3

Allocation:

Sponsor: National Human Genome Research Institute (NHGRI)

Principal Investigator:

Completion Date (primary or actual): June 13, 2011

CT.gov Identifier: NCT00086476

This study will evaluate the effectiveness of 131MIBG in treating malignant pheochromocytoma and whether sensitization medications improve the response to treatment. Pheochromocytoma is a rare type of tumor that usually occurs in the adrenal glands. The tumor cells release chemicals like adrenaline that can cause large increases in blood pressure and pulse rate, with serious health consequences. Tumor in the adrenal glands usually can be removed surgically, but if the pheochromocytoma is malignant-i.e., has spread to many sites in the body-or is located in places where surgery is difficult or impossible, no satisfactory treatment is available. 131MIBG is a combination of an adrenaline-like chemical and a radioactive form of iodine. The 131MIBG attaches to the tumor cells and the high concentration of radioactive iodine kills them. Previous studies using 131MIBG to treat pheochromocytoma had a 36% response rate in terms of complete or partial improvement. This study will examine whether adding other sensitization medications to the 131MIBG treatment regimen will enhance its effectiveness in reducing the size and number of tumors. Patients 18 years of age and older with malignant or inoperable pheochromocytoma may be eligible for this 18-month study. Candidates will be screened with various tests and procedures, which may include a medical history, physical examination, blood and urine tests, lung function studies, electrocardiogram, echocardiogram, computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), and bone scans and other scans using radioactive MIBG and octreotide. Participants will be randomly assigned to one of two treatment groups: 1) 131MIBG plus sensitization medications, or 2) 131MIBG alone. All patients will be hospitalized 3 to 5 days for each 131MIBG treatment. The drug will be infused through a vein (intravenously, or I.V.) over 10 to 30 minutes. Patients will receive up to 3 treatments, separated by at least 3 months. All patients will also take potassium to protect the thyroid gland from radioactive iodine generated by the 131MIBG. The potassium is taken twice a day for 30 days, beginning the day before the 131MIBG treatment. Patients in the sensitization group will receive the following additional drugs for sensitization: methylprednisolone, intravenously a few minutes before 131MIBG treatment; Roaccutan, by mouth (capsules) twice a day for 6 weeks before treatment; Demser, by mouth 3 times a week for 1 week before treatment, and Carbidopa, by mouth every 6 hours for 4 days before treatment. After each treatment, patients will have a clinical evaluation and periodic blood tests to check for adverse side effects of radiotherapy. Follow-up visits at NIH will be scheduled at 12 and 18 months after the first 131MIBG treatment for clinical, laboratory and imaging tests. Patients who had tumors in the lungs before treatment will have lung function tests 1, 3, and 6 months after each treatment. CT, MRI 131MIBG, and PET scanning will be done 1 week before each treatment. Patients who have tumors that have grown by more than 25% and none that have shrunk by more than 50% or who have developed one or more new tumors while on 131MIBG treatment will be taken off the study.

First Posted: December 12, 2001

Condition(s): Pheochromocytoma

Intervention(s): [131]I-MIBG, 6-[18F]Fluorodopamine, [123]I-MIBG

Status: Completed

Enrollment (expected or actual): 32

Allocation:

Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Principal Investigator:

Completion Date (primary or actual): January 8, 2007

CT.gov Identifier: NCT00028106

This is a study to evaluate the safety and efficacy of the IBRF ACP/MCP intervention protocol in patients with severe disorders of consciousness (SDOC).

First Posted: March 2, 2016

Condition(s): Brain Injury

Intervention(s): Polypharmacy using FDA-approved products, Median Nerve Stimulation (MNS), Nutraceutical Supplementation, Standard of Care

Status: Recruiting

Enrollment (expected or actual): 30

Allocation: Randomized

Sponsor: International Brain Research Foundation

Principal Investigator:

Completion Date (primary or actual): March 2017

CT.gov Identifier: NCT02696512

This is a placebo controlled study comparing Rimonabant 5 mg per day for 90 days with placebo for the same period. Objective is to improve walking abilities of spinal cord injury individuals (incomplete lesions) and demonstrate that it is a safe treatment in spinal cord injury population.

First Posted: November 21, 2022

Condition(s): Spinal Cord Injuries

Intervention(s): Rimonabant

Status: Not yet recruiting

Enrollment (expected or actual): 80

Allocation: Randomized

Sponsor: Hospital Nacional de Parapléjicos de Toledo

Principal Investigator: Antonio Oliviero, Antonio Oliviero

Completion Date (primary or actual): November 2023

CT.gov Identifier: NCT05622994

Randomized placebo-controlled safety and feasibility study with crossover design (3 arms). Placebo or Rimonabant 2.5mg or Rimonabant 5mg will be administered for 5 days. Exploratory efficacy will be tested using six-min walking test.

First Posted: June 1, 2022

Condition(s): Spinal Cord Injuries

Intervention(s): Rimonabant

Status: Completed

Enrollment (expected or actual): 8

Allocation: Randomized

Sponsor: Hospital Nacional de Parapléjicos de Toledo

Principal Investigator: Antonio Oliviero, Principal Investigator

Completion Date (primary or actual): June 7, 2022

CT.gov Identifier: NCT05398913

The purpose of this study is to evaluate the safety, tolerability and efficacy of JBT-101 in adult subjects with skin-predominant, dermatomyositis (DM) that is refractory to at least 3 months treatment with hydroxychloroquine.

First Posted: June 9, 2015

Condition(s): Dermatomyositis

Intervention(s): JBT-101, Placebo

Status: Terminated

Enrollment (expected or actual): 22

Allocation: Randomized

Sponsor: Corbus Pharmaceuticals Inc.

Principal Investigator:

Completion Date (primary or actual): August 2017

CT.gov Identifier: NCT02466243

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in adult subjects with cystic fibrosis (CF).

First Posted: June 8, 2015

Condition(s): Cystic Fibrosis

Intervention(s): JBT-101 (lenabasum), Placebo

Status: Completed

Enrollment (expected or actual): 85

Allocation: Randomized

Sponsor: Corbus Pharmaceuticals Inc.

Principal Investigator:

Completion Date (primary or actual): December 28, 2016

CT.gov Identifier: NCT02465450

To investigate the safety, efficacy and pharmacokinetics of single daily oral dose of LY2828360 in male and female subjects with osteoarthritic knee pain

First Posted: March 22, 2011

Condition(s): Osteoarthritis, Knee

Intervention(s): LY2828360, Placebo

Status: Completed

Enrollment (expected or actual): 39

Allocation: Randomized

Sponsor: Eli Lilly and Company

Principal Investigator:

Completion Date (primary or actual): September 2011

CT.gov Identifier: NCT01319929

The Swedish BioFINDER 2 study is a new study that will launch in 2017 and extends the previous cohorts of BioFINDER 1 study (www.biofinder.se). BioFINDER 1 is used e.g. to characterize the role of beta-amyloid pathology in early diagnosis of Alzheimer's disease (AD) using amyloid-PET (18F-Flutemetamol) and Aβ analysis in cerebrospinal fluid samples. The BioFINDER 1 study has resulted in more than 40 publications during the last three years, many in high impact journals, and some the of the results have already had important implications for the diagnostic work-up patients with AD in the clinical routine practice. The original BioFINDER 1 cohort started to include participants in 2008. Since then there has been a rapid development of biochemical and neuroimaging technologies which enable novel ways to the study biological processes involved in Alzheimer's disease in living people. There has also been a growing interest in the earliest stages of AD and other neurodegenerative diseases. With the advent of new tau-PET tracers there is now an opportunity to elucidate the role of tau pathology in the pathogenesis of AD and other tauopathies. The Swedish BioFINDER 2 study has been designed to complement the BioFINDER 1 study and to e.g. address issues regarding the role of tau pathology in different dementias and in preclinical stages of different dementia diseases. Further, the clinical assessments and MRI methods have been further optimized compared to BioFINDER 1.

First Posted: June 5, 2017

Condition(s): Dementia, Alzheimer Disease, Parkinson Disease, Lewy Body Disease, Parkinson-Dementia Syndrome, Frontotemporal Degeneration, Semantic Dementia, Progressive Nonfluent Aphasia, Progressive Supranuclear Palsy, Corticobasal Degeneration, Multiple System Atrophy, Mild Cognitive Impairment

Intervention(s): Flutemetamol F18 Injection, [18F]-RO6958948, Elecsys (Roche) Abeta42, Ttau and Ptau, Lumipulse (Fujirebio) Abeta42, Ttau and Ptau

Status: Recruiting

Enrollment (expected or actual): 1505

Allocation: Non-Randomized

Sponsor: Skane University Hospital

Principal Investigator: Oskar Hansson, Professor in Neurology; Consultant Neurologist

Completion Date (primary or actual): December 31, 2028

CT.gov Identifier: NCT03174938