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
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Condition or disease | Intervention/treatment | Phase |
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Alzheimer's Disease | Other: MRI Other: FDG-PET | Phase 1 |
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 |

Arm | Intervention/treatment |
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Experimental: AD Participants
Participants with a diagnosis of mild-to-moderate AD
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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
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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 |
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.
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 |
Alzheimer's Disease, MRI, PET |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |