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

A

Avid Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Alzheimer's Disease

Treatments

Drug: Flortaucipir F18
Procedure: Brain PET scan

Study type

Interventional

Funder types

Industry

Identifiers

NCT01992380
18F-AV-1451-A03

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

24 participants in 3 patient groups

Healthy Volunteer Subjects
Experimental group
Description:
Healthy males or females 50 years or older with no evidence of cognitive impairment
Treatment:
Procedure: Brain PET scan
Drug: Flortaucipir F18
MCI subjects
Experimental group
Description:
Subjects 50 years or older with mild cognitive impairment (MCI)
Treatment:
Procedure: Brain PET scan
Drug: Flortaucipir F18
Probable AD Subjects
Experimental group
Description:
Subjects 50 years or older with probable Alzheimer's Disease (AD)
Treatment:
Procedure: Brain PET scan
Drug: Flortaucipir F18

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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