Phase 1 Completed N=24 Single-blind Diagnostic

A Study of Flortaucipir PET in Healthy Volunteers and Cognitively Impaired Subjects

Alzheimer's Disease

Source: ClinicalTrials.gov NCT01992380 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2020

Primary outcomePrimary: Test-Retest Reproducibility — 1.342; 1.355 standardized uptake value ratio (SUVr)

Summary

This study will test if two flortaucipir PET scans up to 4 weeks apart in healthy volunteers, MCI and AD subjects provide the same results.

Outcome Measures

Outcome	Result	p-value
PRIMARY Test-Retest Reproducibility	1.459; 1.457	—
PRIMARY Test-Retest Reproducibility	1.459; 1.457	—

Eligibility Criteria

Inclusion Criteria

Healthy Volunteers
Male or female subjects ≥ 50 years of age
Mini-mental state examination (MMSE) ≥ 29
MCI Subjects
Male or female 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
Probable AD Subjects
Male or female subjects ≥ 50 years of age
MMSE > 10
Meet clinical criteria for 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

Exclusion Criteria

Current clinically significant psychiatric disease
Evidence of structural brain abnormalities
Evidence of dementing illness other than AD
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01992380). 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.