Brain Uptake and Safety With Probable Alzheimer's Disease, Amnestic Mild Cognitive Impairment and Healthy Volunteers (ALZ201)

General Electric (GE)

Status and phase

Completed

Phase 2

Conditions

Alzheimer's Disease

Amnestic Mild Cognitive Impairment

Treatments

Drug: AH110690 (18F) Injection

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00785759

ALZ201

Details and patient eligibility

About

Study to Assess Brain Uptake and Safety of AH110690 (18F) Injection in Subjects with Probable Alzheimer's Disease, Amnestic Mild Cognitive Impairment and Healthy Volunteers.

Enrollment

78 patients

Sex

All

Ages

25+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

The subject meets National Institute of Neurological and Communicative Disorders and Stroke; Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for clinically probable AD and Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for dementia of Alzheimer's type.
The subject meets Petersen criteria for amnestic MCI.
The subject has no evidence of cognitive impairment by medical history.

Exclusion criteria

The subject may not be able to complete the study as judged by the investigator.
The subject has received ionising radiation exposure from clinical trials in the last 12 months or has participated in any other clinical study within 30 days of study entry.
The subject has known allergies to [18F]AH110690 or [11C]PIB or their constituents.
The subject is pregnant or breast-feeding.
The subject has a history of alcohol and/or drug abuse within the last 2 years based upon a review of medical records.
The subject has a contraindication for MRI (including, but not limited to, claustrophobia, pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant).
The subject has a history of head injury with loss of consciousness.