Alzheimer's Disease Clinical Trial
Official title:
An Open Label, Multicenter Study Evaluating the Imaging Characteristics of a Follow up 18F-AV-1451 Scan in Subjects That Participated in the Confirmatory Cohort of 18F-AV-1451-A05
| Verified date | August 2020 |
| Source | Avid Radiopharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will evaluate longitudinal change of tau deposition as measured by flortaucipir F 18 uptake over time.
| Status | Completed |
| Enrollment | 79 |
| Est. completion date | August 28, 2017 |
| Est. primary completion date | August 28, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years and older |
| Eligibility |
Inclusion Criteria: - Confirmatory cohort subjects who completed the 18F-AV-1451-A05 (NCT02016560) study Exclusion Criteria: - Current clinically significant cardiovascular disease, ECG abnormalities, risk factors for Torsades de Pointes (TdP), or are taking drugs known to cause QT prolongation - Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer - Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception - Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session - Have received or participated in a trial with investigational medications in the past 30 days |
| Country | Name | City | State |
|---|---|---|---|
| United States | Boston University School of Medicine | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | Neuropsychiatric Research Center of Southwest Florida | Fort Myers | Florida |
| United States | Institute for Brain Aging and Dementia, UC Irvine | Irvine | California |
| United States | Las Vegas Radiology | Las Vegas | Nevada |
| United States | New York University Center for Brain Health | New York | New York |
| United States | 21st Century Oncology | Newport Beach | California |
| United States | Compass Research, LLC | Orlando | Florida |
| United States | University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Banner Alzheimer's Institute | Phoenix | Arizona |
| United States | Butler Hospital | Providence | Rhode Island |
| United States | Rhode Island Hospital | Providence | Rhode Island |
| United States | Alzheimer's Disease Center, UC Davis | Sacramento | California |
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| United States | Meridien Research | Saint Petersburg | Florida |
| United States | California Medical Clinic for Headache | Santa Monica | California |
| United States | Imaging Endpoints | Scottsdale | Arizona |
| United States | Mayo Clinic Arizona | Scottsdale | Arizona |
| United States | Banner Sun Health Research Institute | Sun City | Arizona |
| United States | University of South Florida Health Byrd Alzheimer's Institute | Tampa | Florida |
| United States | Premiere Research Institute | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Avid Radiopharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Tau Deposition Over Time by Diagnostic Group and Amyloid Status | Change in flortaucipir standardized uptake value ratio (SUVr) over 18 months. For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. A positive change in SUVr represents an increase in tau deposition in the brain. Change = 18 month SUVr - baseline SUVr obtained in Study A05. | 18 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05040048 -
Taxonomy of Neurodegenerative Diseases : Observational Study in Alzheimer's Disease and Parkinson's Disease
|
||
| Withdrawn |
NCT03316898 -
A FDG-PET Study of AGN-242071 Added to Standard-of-Care (Donepezil ± Memantine) for the Treatment of Participants With Mild to Moderate Alzheimer's Disease
|
Phase 1 | |
| Withdrawn |
NCT02860065 -
CPC-201 Alzheimer's Disease Type Dementia: PET Study
|
Phase 2 | |
| Completed |
NCT01315639 -
New Biomarker for Alzheimer's Disease Diagnostic
|
N/A | |
| Not yet recruiting |
NCT03740178 -
Multiple Dose Trial of MK-4334 in Participants With Alzheimer's Clinical Syndrome (MK-4334-005)
|
Phase 1 | |
| Recruiting |
NCT05607615 -
A 6-Month Study to Evaluate the Safety & Potential Efficacy of Trappsol Cyclo in Patients With Early Alzheimer's Disease
|
Phase 2 | |
| Terminated |
NCT03307993 -
Positron Emission Tomography (PET) Study in Patients With Alzheimer's Disease
|
Phase 1 | |
| Recruiting |
NCT02912936 -
A Medium Chain Triglyceride Intervention for Patients With Alzheimer Disease
|
N/A | |
| Active, not recruiting |
NCT02899091 -
Evaluation of the Safety and Potential Therapeutic Effects of CB-AC-02 in Patients With Alzheimer's Disease
|
Phase 1/Phase 2 | |
| Completed |
NCT02907567 -
Clinical Trial of CT1812 in Mild to Moderate Alzheimer's Disease
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT02868905 -
Identification of Epigenetic Markers Common to Obesity and Alzheimer's Disease in Women
|
N/A | |
| Completed |
NCT02516046 -
18F-AV-1451 Autopsy Study
|
Phase 3 | |
| Completed |
NCT02580305 -
SUVN-502 With Donepezil and Memantine for the Treatment of Moderate Alzheimer's Disease- Phase 2a Study
|
Phase 2 | |
| Terminated |
NCT02521558 -
Effectiveness of Home-based Electronic Cognitive Therapy in Alzheimer's Disease
|
N/A | |
| Recruiting |
NCT02247180 -
Cognitive Rehabilitation in Alzheimer`s Disease
|
N/A | |
| Terminated |
NCT02220738 -
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABT-957 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
|
Phase 1 | |
| Completed |
NCT02260167 -
Treatment of Alzheimer's and Dementia With the Metabolism, Infections, Nutrition, Drug Elimination (MIND) Protocol
|
N/A | |
| Completed |
NCT02256306 -
The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study
|
N/A | |
| Completed |
NCT02317523 -
Alzheimer's Caregiver Coping: Mental and Physical Health
|
N/A | |
| Completed |
NCT02089555 -
African American Alzheimer's Progression Markers - CSF and Neuro-Imaging
|
N/A |