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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)

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ClinicalTrials.gov Identifier: NCT00757939
Recruitment Status : Completed
First Posted : September 23, 2008
Last Update Posted : August 11, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Alzheimer's Disease Other: MRI Other: FDG-PET Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : September 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Regional cerebral blood flow, as measured by dASL. [ Time Frame: 1 week, 6 and 12 months ]
    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 :
  1. Rate of cerebral glucose consumption, MRglc, as measured by fludeoxyglucose-PET (FDG-PET) [ Time Frame: 12 months ]
    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.

  2. Resting state functional MRI blood-oxygen-level-dependent (fMRI BOLD) response [ Time Frame: 1 week, 6 and 12 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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No Contacts or Locations Provided
More Information
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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT00757939    
Other Study ID Numbers: 0000-068
2008_547
First Posted: September 23, 2008    Key Record Dates
Last Update Posted: August 11, 2015
Last Verified: August 2015
Keywords provided by Merck Sharp & Dohme LLC:
Alzheimer's Disease, MRI, PET
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders