Clinical trial NCT04474405: Exploratory Evaluation of Flortaucipir Injection in Healthy Volunteers and Cognitively Impaired Subjects
Official title: An Exploratory Evaluation of the Tau Protein Binding Properties, Whole-Body Biodistribution and Safety of 18F-AV-1451 Injection in Healthy Volunteers and Cognitively Impaired Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Avid Radiopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-07-16
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This early phase 1 study explored the brain uptake, retention, and safety of flortaucipir and obtained preliminary information regarding dosimetry of flortaucipir.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers had an Mini-Mental State Examination (MMSE) score of ≥ 29;
* MCI due to Alzheimer's disease (AD) consistent with National Institute on Aging (NIA)-Alzheimer's Association working group's on diagnostic guidelines for AD (Alzheimer's Dementia 7:270-9, 2011)
* Possible or probable AD: Met clinical criteria for possible or probable AD based on the NIA-Alzheimer's Association working group's on diagnostic guidelines for AD (Alzheimer's Dementia 7:263-9, 2011)

Exclusion Criteria:

* Current clinically significant psychiatric disease.
* Evidence of structural abnormalities such as major stroke or mass on MRI that would have made a diagnosis of impairment due to AD unlikely or was likely to interfere with interpretation of a PET scan on MRI.
* Claustrophobic or otherwise unable to tolerate the imaging procedure.
* Current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram (including, but not limited to, corrected QT interval \>450 msec).
* Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
* History of alcohol abuse or substance abuse or dependence
* Female subjects of childbearing potential who were not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception.
* Required medications with a narrow therapeutic window
* Received a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to imaging session
* Receiving any investigational medications or had participated in a trial with investigational medications within the last 30 days

Primary outcomes:
measure: Brain Flortaucipir Uptake
timeFrame: 80-100 minutes postdose
measure: Flortaucipir Whole Body Effective Dose
timeFrame: injection to 6 hours postdose
Secondary outcomes:
measure: Flortaucipir PET Correlations With Cognitive Assessments (Mini-mental State Exam)
timeFrame: at baseline
measure: Flortaucipir PET Correlations With Cognitive Assessments Cognitive Assessments (Digit Symbol Substitution Test)
timeFrame: at baseline
measure: Flortaucipir PET Correlations With Cognitive Assessments Cognitive Assessments (Alzheimer's Disease Assessment Scale)
timeFrame: at baseline
Other outcomes:
Locations:
city: Cypress
country: United States
facility: WCCT Global, LLC
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
Study officials:
affiliation: Avid Radiopharmaceuticals, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: