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

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

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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