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

NCT00785759 | Completed Phase 2 DMC

• 1 other identifier: ALZ201
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease; Amnestic Mild Cognitive Impairment

Keywords

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Interventions

AH110690 (18F) Injection DRUG

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).

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead
• i3 Statprobe: collaborator
• Medpace, Inc.: collaborator
• Hvidovre University Hospital: collaborator

Study Sites (1)

GE Healthcare

Oslo, Norway

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Injections

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Carl G Torres, Ph.D.

  GE Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 4, 2008
• First Posted: November 5, 2008
• Study Start: September 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 7, 2009

Record last verified: 2009-12

Locations

NO (1)