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

Phase 2

Completed

• Conditions: Alzheimer's Disease; Amnestic Mild Cognitive Impairment

• Registration Number: NCT00785759
• Lead Sponsor: GE Healthcare

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-11-04
• Study First Submitted QC: 2008-11-04
• Study First Posted: 2008-11-05
• Primary Completion: 2009-03
• Status Verified: 2009-12
• Study Completion: 2009-12
• Last Update Submitted: 2009-12-04
• Last Update Posted: 2009-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Examine the efficacy and determine visual assessment of raised [18F] brain uptake for separating subjects with probable Alzheimer's Disease from healthy volunteers and assigning amnestic mild cognitive impairment cases to an AD or HV category.	September 2008 - February 2009

Secondary Outcome Measures

Name	Time	Method
Examine the efficacy and parameters of brain [18F] uptake for separating 25 subjects with probable AD from 25 HV, assigning 20 amnestic MCI cases to an AD or HV category by measuring ranges of regional cerebral to cerebellum tracer uptake ratios.	September 2008 - February 2009

Trial Locations

Locations (1)

GE Healthcare; 🇳🇴 Oslo, Norway