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

Overview

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.

Full Title of Study: “An Open-label 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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2009

Interventions

  • Drug: AH110690 (18F) Injection
    • All subjects will receive an I.V. dose of [18F]AH110690 (less than 10 mg of total AH110690). The target activity of a single administration of [18F]AH110690 will be 185 MBq (equivalent to a dose of approximately 6 mSv).

Clinical Trial Outcome Measures

Primary Measures

  • 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.
    • Time Frame: September 2008 – February 2009

Secondary Measures

  • 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.
    • Time Frame: September 2008 – February 2009

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 25 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • GE Healthcare
  • Collaborator
    • i3 Statprobe
  • Provider of Information About this Clinical Study
    • Carl G Torres Ph.D., GE Healthcare
  • Overall Official(s)
    • Carl G Torres, Ph.D., Study Director, GE Healthcare

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.