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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:
ClinicalTrials.gov Identifier:
NCT00785759
First Posted: November 5, 2008
Last Update Posted: December 7, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
i3 Statprobe
Medpace, Inc.
Hvidovre Hospital Center Demark Danish Research Centre for Magnetic Resonance
Information provided by:
GE Healthcare
  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: Intervention Model: Single Group Assignment
Masking: None (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:


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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Carl G Torres Ph.D., GE Healthcare
ClinicalTrials.gov Identifier: NCT00785759     History of Changes
Other Study ID Numbers: ALZ201
First Submitted: November 4, 2008
First Posted: November 5, 2008
Last Update Posted: December 7, 2009
Last Verified: December 2009

Keywords provided by GE Healthcare:
Alzheimer's Disease

Additional relevant MeSH terms:
Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders