Overview

This trial is active, not recruiting.

Condition alzheimer's disease
Treatments florbetapir f 18, 18f-av-1451
Phase phase 2/phase 3
Sponsor Avid Radiopharmaceuticals
Start date December 2013
End date August 2017
Trial size 383 participants
Trial identifier NCT02016560, 18F-AV-1451-A05

Summary

This is a cross-sectional and longitudinal study that will evaluate imaging characteristics of 18F-AV-1451 in cognitively healthy volunteers, mild cognitive impairment (MCI) and Alzheimer's disease (AD) subjects.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (outcomes assessor)
Primary purpose diagnostic
Arm
(Experimental)
Subjects will receive an IV injection, 370 megabecquerel (MBq) (10 millicurie [mCi]), single dose of florbetapir F 18 at baseline. Cross-sectional and longitudinal subjects will receive an IV injection, 370 MBq (10 mCi), single dose of 18F-AV-1451 at baseline. Longitudinal subjects only will receive an IV injection, 370 MBq (10 mCi) of 18F-AV-1451 at 9 and 18 months.
florbetapir f 18 Amyvid
18f-av-1451 T807
(Experimental)
Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of florbetapir F 18 at baseline. Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of 18F-AV-1451 at baseline, 9 months and 18 months.
florbetapir f 18 Amyvid
18f-av-1451 T807
(Experimental)
Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of florbetapir F 18 at baseline. Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of 18F-AV-1451 at baseline, 9 months and 18 months.
florbetapir f 18 Amyvid
18f-av-1451 T807
(Experimental)
Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of florbetapir F 18 and 18F-AV-1451 at baseline.
florbetapir f 18 Amyvid
18f-av-1451 T807

Primary Outcomes

Measure
Cross-sectional 18F-AV-1451 Imaging Results
time frame: 80-130 minutes post injection
Change in tau deposition over time
time frame: 18 months

Secondary Outcomes

Measure
18F-AV-1451 imaging in healthy individuals
time frame: 80-130 minutes post-injection

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: Exploratory Cognitively Healthy Subjects - ≥ 20 to ≤ 40 years of age OR ≥ 50 years of age - Mini-mental state examination (MMSE) ≥ 29 - No significant history of cognitive impairment Exploratory MCI Subjects - ≥ 50 years of age - MMSE ≥ 24 - Have MCI consistent with National Institute on Aging-Alzheimer's Association (NIA-AA) working group's diagnostic guidelines for AD - Have a study partner that can report on subject's activities of daily living Exploratory AD Subjects - ≥ 50 years of age - MMSE > 10 - Have possible or probable AD based on the NIA-AA working group's diagnostic guidelines for AD - Have a study partner that can report on subject's activities of daily living Confirmatory Subjects - ≥ 50 years of age - MMSE ≥ 20 and ≤ 27 - Cognitively impaired subjects with either MCI or dementia with a suspected neurodegenerative cause - Have a study partner that can report on subject's activities of daily living Exclusion Criteria: - Current clinically significant psychiatric disease - Evidence of structural brain abnormalities - History of moderate or severe traumatic brain injury - Current clinically significant cardiovascular disease or ECG abnormalities, or additional risk factors for Torsades de Pointes - Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer - History of alcohol or substance abuse or dependence - Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception - Have received or participated in a trial with investigational medications in the past 30 days - Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session.

Additional Information

Official title An Open Label, Multicenter Study, Evaluating the Safety and Imaging Characteristics of 18F-AV-1451 in Cognitively Healthy Volunteers, Subjects With Mild Cognitive Impairment, and Subjects With Alzheimer's Disease
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Avid Radiopharmaceuticals.