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

Alzheimer's Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00785759
• Other study ID #: ALZ201
• 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

• Alzheimer Disease
• Alzheimer's Disease
• Amnestic Mild Cognitive Impairment
• Cognition Disorders
• Mild Cognitive Impairment

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