Phase 1
Completed N=89
Flortaucipir PET Imaging in the Preclinical, Prodromal and Dementia Phases of Alzheimer's Disease
Source: ClinicalTrials.gov NCT04468347 ↗Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Flortaucipir PET Imaging (Quantitative) — 1.31; 1.13; 1.15; 1.08 standardized uptake value ratio (SUVr) — p=<0.0001
Summary
A Phase 1 study designed to evaluate imaging characteristics of flortaucipir in the preclinical, prodromal and dementia phases of Alzheimer's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Flortaucipir PET Imaging (Quantitative) |
1.31; 1.13; 1.15; 1.08; 1.04; 1.07 | <0.0001 sig |
| PRIMARY Number of Participants With Advanced AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status |
2; 3; 9; 0; 2; 2 | 0.1998 |
| PRIMARY Number of Participants With AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status |
2; 4; 11; 0; 2; 1 | 0.0646 |
Eligibility Criteria
Inclusion Criteria
- Meet all inclusion criteria for the AIBL study protocol, with amyloid PET conducted or planned and MRI available
- Subjects in the MCI and AD groups required to have a reliable caregiver capable of providing information about the subjects' symptoms
Exclusion Criteria
- lifetime history of schizophrenia, schizoaffective disorder, or bipolar disorder
- history of electroconvulsive therapy
- MRI contraindicated
- claustrophobic or, otherwise, unable to tolerate the imaging procedure
- current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram
- history of additional risk factors for Torsades de Pointes
- current clinically significant infectious disease, endocrine or metabolic disease, or pulmonary, renal, or hepatic impairment that the investigator believes would affect study participation
- history of cancer (other than skin or in situ prostate cancer) within the previous 5 years
- current drug or alcohol abuse/dependence
- history of alcohol abuse/dependence with 2 years of the onset of the symptoms of dementia
- females of childbearing potential who were not surgically sterile, not refraining from sexual activity, or not using reliable methods of contraception
Data sourced from ClinicalTrials.gov (NCT04468347). 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.