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

This study has been completed.
Sponsor:
Collaborators:
i3 Statprobe
Medpace, Inc.
Hvidovre Hospital Center Demark Danish Research Centre for Magnetic Resonance
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00785759
First received: November 4, 2008
Last updated: December 4, 2009
Last verified: December 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Amnestic Mild Cognitive Impairment
 Drug: AH110690 (18F) Injection
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GE Healthcare:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Enrollment: 78
Study Start Date: September 2008
Study Completion Date: December 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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).
  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00785759

Locations
Norway
GE Healthcare
Oslo, Norway
Sponsors and Collaborators
GE Healthcare
i3 Statprobe
Medpace, Inc.
Hvidovre Hospital Center Demark Danish Research Centre for Magnetic Resonance
Investigators
Study Director: Carl G Torres, Ph.D. GE Healthcare
  More Information

No publications provided

Responsible Party: Carl G Torres Ph.D., GE Healthcare
ClinicalTrials.gov Identifier: NCT00785759     History of Changes
Other Study ID Numbers: ALZ201
Study First Received: November 4, 2008
Last Updated: December 4, 2009
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Medicines Agency

Keywords provided by GE Healthcare:
Alzheimer's Disease

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013