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

NCT ID: NCT00785759

Last Updated: 2009-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer's Disease Amnestic Mild Cognitive Impairment

Keywords

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Alzheimer's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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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).

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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i3 Statprobe

INDUSTRY

Sponsor Role collaborator

Medpace, Inc.

INDUSTRY

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role collaborator

GE Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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GE Healthcare

Principal Investigators

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Carl G Torres, Ph.D.

Role: STUDY_DIRECTOR

GE Healthcare

Locations

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GE Healthcare

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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ALZ201

Identifier Type: -

Identifier Source: org_study_id