Phase 3
Completed N=223
Analysis of 18F-AV-1451 PET Imaging in Cognitively Healthy, MCI, and AD Subjects
Source: ClinicalTrials.gov NCT02016560 ↗Enrolled (actual)
223
Serious AEs
0.3%
Results posted
Aug 2020
Primary outcomePrimary: Confirmatory Phase: Relationship Between Neocortical Flortaucipir Uptake and the Subsequent Rate of Cognitive Decline — 36; 31; 27; 37 Participants — p=0.067
◆ Published Evidence
Established
53citations · ~11 / year
Aggregated Tau Measured by Visual Interpretation of Flortaucipir Positron Emission Tomography and the Associated Risk of Clinical Progression of Mild Cognitive Impairment and Alzheimer Disease: Results From 2 Phase III Clinical Trials.
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).
Linked Publications
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Aggregated Tau Measured by Visual Interpretation of Flortaucipir Positron Emission Tomography and the Associated Risk of Clinical Progression of Mild Cognitive Impairment and Alzheimer Disease: Results From 2 Phase III Clinical Trials.
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 |
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) and the linked publication. 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. Informational only — not medical advice.