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

Primary Purpose

Alzheimer's Disease, Amnestic Mild Cognitive Impairment

Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
AH110690 (18F) Injection
Sponsored by
GE Healthcare
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer's Disease focused on measuring Alzheimer's Disease

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • GE Healthcare

Outcomes

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.

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.

Full Information

First Posted
November 4, 2008
Last Updated
December 4, 2009
Sponsor
GE Healthcare
Collaborators
i3 Statprobe, Medpace, Inc., Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00785759
Brief Title
Brain Uptake and Safety With Probable Alzheimer's Disease, Amnestic Mild Cognitive Impairment and Healthy Volunteers
Acronym
ALZ201
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
GE Healthcare
Collaborators
i3 Statprobe, Medpace, Inc., Hvidovre University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Amnestic Mild Cognitive Impairment
Keywords
Alzheimer's Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
AH110690 (18F) Injection
Intervention Description
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).
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl G Torres, Ph.D.
Organizational Affiliation
GE Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
GE Healthcare
City
Oslo
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

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

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