Phase 2
Completed N=79
Follow up 18F-AV-1451 Scan in Confirmatory Cohort Subjects From Study 18F-AV-1451-A05
Source: ClinicalTrials.gov NCT02795780 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Change in Tau Deposition Over Time by Diagnostic Group and Amyloid Status — 0.0205; -0.0912; 0.0352; -0.0124 standardized uptake value ratio (SUVr) — p=0.0166
Summary
This study will evaluate longitudinal change of tau deposition as measured by flortaucipir F 18 uptake over time.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Tau Deposition Over Time by Diagnostic Group and Amyloid Status |
0.0205; -0.0912; 0.0352; -0.0124 | 0.0166 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02795780). 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.