A Phase II Trial of 18F-AV-45 Positron Emission Tomography (PET) Imaging in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)

Avid Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease; Mild Cognitive Impairment

Treatments: Drug: florbetapir F 18

Study type: Interventional

Funder types: Industry

Identifiers

NCT00702143

18F-AV-45-A05

Details and patient eligibility

About

Evaluate 18F-AV-45 positron emission tomography (PET) imaging for distinguishing healthy control subjects, from subjects with Alzheimer's disease (AD) or Mild cognitive impairment (MCI).

Enrollment: 184 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria AD:

• Male or female >=50 years of age
• Meet National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS) criteria for probable AD with MMSE score of 10-24

Inclusion Criteria MCI:

• Male or female >=50 years of age
• Have a Clinical Dementia Rating (CDR) of 0.5
• MMSE >24

Normal subjects:

• Male or female >=50 years of age
• MMSE >=29
• Normal on psychometric test battery at screening
• Provide informed consent

Exclusion Criteria:

• Have a history or current diagnosis of other neurologic disease
• Have had or currently have a diagnosis of other neurodegenerative disease
• Have participated in experimental therapy targeted to amyloid plaque

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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184 participants in 3 patient groups

AD subjects

Experimental group

Treatment:

Drug: florbetapir F 18

MCI Subjects

Experimental group

Description:

MCI (mild cognitive impairment)

Treatment:

Drug: florbetapir F 18

Healthy controls

Experimental group

Treatment:

Drug: florbetapir F 18