A Study to Assess Regional Cerebral Blood Flow as an Alzheimer's Disease Biomarker Compared to Positron Emission Tomography in Patients With Mild-to-Moderate Alzheimer's Disease and Cognitively Normal Elderly Subjects (Study MK-0000-068)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00757939
First received: September 19, 2008
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

The aim of the study is to determine if regional cerebral blood flow, measured by dynamic arterial spin labeling (dASL), can be a biomarker for stage of Alzheimer's disease. The study is designed to be conducted in 2 parts in participants with mild to moderate Alzheimer's disease, and participants with normal cognition. Various imaging studies will be done using magnetic resonance imaging (MRI) and positron emission tomography (PET) along with neurocognitive assessments. Participants who meet the study-entry criteria will have up to 8 study visits. Repeat imaging studies may be required if the initial data are incomplete or un-interpretable. The maximum number of PET scans during the study will be limited to four.


Condition Intervention Phase
Alzheimer's Disease
Other: MRI
Other: FDG-PET
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Regional cerebral blood flow, as measured by dASL. [ Time Frame: 1 week, 6 and 12 months ] [ Designated as safety issue: No ]
    Part I: regional cerebral blood flow, measured by dASL at Baseline and 1 week in AD participants and cognitively normal controls. Part II: regional cerebral blood flow, measured at 6 months and 12 months in AD participants and normal control participants.


Secondary Outcome Measures:
  • Rate of cerebral glucose consumption, MRglc, as measured by fludeoxyglucose-PET (FDG-PET) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Regional cerebral rate of glucose consumption, MRglc, as assessed by FDG-PET will be measured at Baseline in (Part I) and at 12 months in (Part II), in AD participants and normal control participants.

  • Resting state functional MRI blood-oxygen-level-dependent (fMRI BOLD) response [ Time Frame: 1 week, 6 and 12 months ] [ Designated as safety issue: No ]
    The resting state fMRI BOLD (blood-oxygen-level-dependent) signal will be evaluated for 'Goodness-of-Fit' to the default mode network at Baseline, 1 week, and 6 and 12 months in AD participants and normal control participants.


Enrollment: 40
Study Start Date: September 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AD Participants
Participants with a diagnosis of mild-to-moderate AD
Other: MRI
During the study all participants will have 4 total MRI scans: baseline, 1 week, 6 and 12 months.
Other: FDG-PET
2 to 4 PET scans will be done over 12 months, 2 planned and 2 more if data from any of these are un-interpretable
Experimental: Cognitively Normal Elderly Participants
Elderly participants with no cognitive impairment
Other: MRI
During the study all participants will have 4 total MRI scans: baseline, 1 week, 6 and 12 months.
Other: FDG-PET
2 to 4 PET scans will be done over 12 months, 2 planned and 2 more if data from any of these are un-interpretable

  Eligibility

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

Inclusion Criteria:

The prospective participant must meet, at least, all of the criteria below (among others determined by the study staff) to be eligible for study participation.

The participant:

  • Has mild-to-moderate Alzheimer's Disease (AD), OR is considered cognitively normal;
  • Has been on stable doses of any regularly used medications for 4 weeks prior to study start;
  • Must have been on a stable dose for 12 weeks prior to study start, of any medications taken for AD.

Exclusion Criteria:

If the prospective participant meets any of the criteria below (among others determined by the study staff) they will NOT be eligible for study participation.

The participant:

  • Is living in a nursing home or skilled nursing facility;
  • Has severe AD;
  • Cannot undergo MRI;
  • Cannot undergo PET scans;
  • Has a history of neurological or neurodegenerative disorders, other than AD within 2 years prior to study start;
  • Has taken Tacrine or anti-parkinsonian medications within 3 months of study start;
  • Has taken corticosteroids, blood thinners, narcotic analgesics, benzodiazepines, or certain antihistamines within 1 month of study start;
  • Initiates, discontinues, or changes the dose of any AD treatment during the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00757939     History of Changes
Other Study ID Numbers: 0000-068, 2008_547
Study First Received: September 19, 2008
Last Updated: August 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Merck Sharp & Dohme Corp.:
Alzheimer's Disease, MRI, PET

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014