A Study to Evaluate dASL Imaging as a Biomarker for Alzheimer's Disease - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00757939

Purpose

This study will assess the suitability of regional cerebral blood flow measured by dynamic arterial spin labeling as a biomarker for Alzheimer's disease

Condition	Intervention	Phase
Alzheimer's Disease	Other: dASL imaging	Phase I

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Bio-equivalence Study
Official Title:	A Two-Part Cross-Sectional and Longitudinal Study to Assess Regional Cerebral Blood Flow by Dynamic Arterial Spin Labeling as an Alzheimer's Disease Biomarker as Compared to FDG-PET in Patients With Mild-to-Moderate Alzheimer's Disease and Cognitively Normal Elderly Subjects

Further study details as provided by Merck:

Primary Outcome Measures:

Evaluation of whether regional cerebral blood flow as measured by dASL is a biomarker for AD stage [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparison of regional blood flow assessed by dASL with other AD biomarkers [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	September 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental dASL Imaging	Other: dASL imaging Patients will have 8 total visits including screening, assessments, and imaging over a 12 month period. Imaging will include dASL, fMRI, FDG-PET, and VBM.

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patient has mild-to-moderate Alzheimer's Disease (AD), OR patient is considered cognitively normal
Patient has been on stable doses of any regularly used medications for 4 weeks prior to study start
Patients taking medications for AD must be at a stable dose for 12 weeks prior to study start

Exclusion Criteria:

Patient is living in a nursing home or skilled nursing facility
Patient has severe AD
Patient cannot undergo MRI
Patient cannot undergo PET scans
Patient has a history of neurological or neurodegenerative disorders other than AD within 2 years prior to study start
Patient has taken Tacrine or anti-parkinsonian medications within 3 months of study start
Patient has taken corticosteroids, blood thinners, narcotic analgesics, benzodiazepines, or certain antihistamines within 1 month of study start
Patient initiates, discontinues, or changes the dose of any AD treatment during the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757939

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_547, 068
Study First Received:	September 19, 2008
Last Updated:	February 16, 2009
ClinicalTrials.gov Identifier:	NCT00757939 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases

Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on May 07, 2009