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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00785759
Other study ID # ALZ201
Secondary ID
Status Completed
Phase Phase 2
First received November 4, 2008
Last updated December 4, 2009
Start date September 2008
Est. completion date December 2009

Study information

Verified date December 2009
Source GE Healthcare
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health ProductsDenmark: Danish Medicines Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 78
Est. completion date December 2009
Est. primary completion date March 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 25 Years and older
Eligibility 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
Norway GE Healthcare Oslo

Sponsors (4)

Lead Sponsor Collaborator
GE Healthcare Hvidovre Hospital Center Demark Danish Research Centre for Magnetic Resonance, i3 Statprobe, Medpace, Inc.

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. September 2008 - February 2009 No
Secondary 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. September 2008 - February 2009 No
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