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

December 4, 2009 updated by: GE Healthcare

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 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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • GE Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
September 2008 - February 2009

Secondary Outcome Measures

Outcome Measure
Time Frame
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
September 2008 - February 2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GE Healthcare

Collaborators

Hvidovre University Hospital
Medpace, Inc.
i3 Statprobe

Investigators

  • Study Director: Carl G Torres, Ph.D., GE Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

November 4, 2008

First Submitted That Met QC Criteria

November 4, 2008

First Posted (ESTIMATE)

November 5, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 7, 2009

Last Update Submitted That Met QC Criteria

December 4, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALZ201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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