Back to resultsA 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)
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MRI
FDG-PET
Sponsored by
About this trial
This is an interventional diagnostic trial for Alzheimer's Disease focused on measuring Alzheimer's Disease, MRI, PET
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
AD Participants
Cognitively Normal Elderly Participants
Arm Description
Participants with a diagnosis of mild-to-moderate AD
Elderly participants with no cognitive impairment
Outcomes
Primary Outcome Measures
Regional cerebral blood flow, as measured by dASL.
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)
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
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.
Full Information
NCT ID
NCT00757939
First Posted
September 19, 2008
Last Updated
August 10, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00757939
Brief Title
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)
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 Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's Disease, MRI, PET
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AD Participants
Arm Type
Experimental
Arm Description
Participants with a diagnosis of mild-to-moderate AD
Arm Title
Cognitively Normal Elderly Participants
Arm Type
Experimental
Arm Description
Elderly participants with no cognitive impairment
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
During the study all participants will have 4 total MRI scans: baseline, 1 week, 6 and 12 months.
Intervention Type
Other
Intervention Name(s)
FDG-PET
Intervention Description
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
Primary Outcome Measure Information:
Title
Regional cerebral blood flow, as measured by dASL.
Description
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.
Time Frame
1 week, 6 and 12 months
Secondary Outcome Measure Information:
Title
Rate of cerebral glucose consumption, MRglc, as measured by fludeoxyglucose-PET (FDG-PET)
Description
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.
Time Frame
12 months
Title
Resting state functional MRI blood-oxygen-level-dependent (fMRI BOLD) response
Description
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.
Time Frame
1 week, 6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
12. IPD Sharing Statement
Learn more about this trial
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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