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: September 17, 2013
Last verified: September 2013

September 19, 2008
September 17, 2013
September 2008
October 2010   (final data collection date for primary outcome measure)
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.
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 ]
Complete list of historical versions of study NCT00757939 on ClinicalTrials.gov Archive Site
  • 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.
Comparison of regional blood flow assessed by dASL with other AD biomarkers [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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)
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Alzheimer's Disease
  • 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: AD Participants
    Participants with a diagnosis of mild-to-moderate AD
    Interventions:
    • Other: MRI
    • Other: FDG-PET
  • Experimental: Cognitively Normal Elderly Participants
    Elderly participants with no cognitive impairment
    Interventions:
    • Other: MRI
    • Other: FDG-PET
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
October 2010
October 2010   (final data collection date for primary outcome measure)

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.
Both
55 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00757939
0000-068, 2008_547
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP