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)

NCT00757939 | Completed Phase 1

• 2 other identifiers: 0000-0682008_547
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease, MRI, PET

Outcome Measures

Primary Outcomes (1)

• 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.

  1 week, 6 and 12 months

Secondary Outcomes (2)

• Rate of cerebral glucose consumption, MRglc, as measured by fludeoxyglucose-PET (FDG-PET)

  12 months

• Resting state functional MRI blood-oxygen-level-dependent (fMRI BOLD) response

  1 week, 6 and 12 months

Study Arms (2)

AD Participants

EXPERIMENTAL

Participants with a diagnosis of mild-to-moderate AD

Other: MRI; Other: FDG-PET

Cognitively Normal Elderly Participants

EXPERIMENTAL

Elderly participants with no cognitive impairment

Other: MRI; Other: FDG-PET

Interventions

MRI OTHER

During the study all participants will have 4 total MRI scans: baseline, 1 week, 6 and 12 months.

AD Participants; Cognitively Normal Elderly Participants

FDG-PET OTHER

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

AD Participants; Cognitively Normal Elderly Participants

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2008
• First Posted: September 23, 2008
• Study Start: September 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: August 11, 2015

Record last verified: 2015-08