Phase 3
N=223
Analysis of 18F-AV-1451 PET Imaging in Cognitively Healthy, MCI, and AD Subjects
Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02016560 ↗Enrolled (actual)
223
Serious AEs
0.3%
Results posted
Aug 2020
Primary outcome: Primary: Confirmatory Phase: Relationship Between Neocortical Flortaucipir Uptake and the Subsequent Rate of Cognitive Decline — 36; 31; 27; 37 Participants — p=0.067
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- florbetapir F 18 (Drug); Flortaucipir F18 (Drug); Brain PET Scan (Procedure)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Avid Radiopharmaceuticals
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Confirmatory Phase: Relationship Between Neocortical Flortaucipir Uptake and the Subsequent Rate of Cognitive Decline |
36; 31; 27; 37 | 0.067 |
| PRIMARY Exploratory Phase: Cross-sectional Flortaucipir Imaging Results |
1.53; 1.26; 1.08; 1.03; 0.99; 0.98 | <0.0001 sig |
| PRIMARY Exploratory Phase: Longitudinal Change in Tau Deposition Over Time, by Amyloid Status |
0.052359; 0.000655 | <0.0001 sig |
| SECONDARY Confirmatory Phase: Diagnostic Performance of Flortaucipir Visual Read |
59.6; 65.5; 53.8; 65.5; 55.8; 65.5 | — |
| SECONDARY Exploratory Phase: Correlation Between Flortaucipir SUVr and Age |
1.0083; 1.0203; 1.0110; 1.0010; 1.0048 | 0.4361 |
Summary
A Phase 2/3 cross-sectional and longitudinal observational study evaluating imaging characteristics of flortaucipir in control subjects and patients with clinically defined MCI and AD dementia (AD).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02016560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.