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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Arterial Spin Labeling (ASL) MRI for Cognitive Decline

NCT01727622

Mild Cognitive Impairment Alzheimer's Disease

COMPLETED

Relationship Between Down Syndrome (DS) and Alzheimer's Disease (AD)

NCT02759887

Down Syndrome Alzheimer's Dementia

COMPLETED NA

Neuroimaging Markers of Alzheimer Disease: a Longitudinal Population Study

NCT01582919

Dementia Alzheimer Disease

COMPLETED NA

FluoroAv45 Imaging Research-in Alzheimer's Disease

NCT01325259

Alzheimer's Disease Mild Cognitive Impairment

COMPLETED PHASE2

Magnetic Resonance Imaging for the Study of Patients With Neurological Disorders

NCT00001362

Amnesia Dementia Healthy +1 more

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AD Participants

Participants with a diagnosis of mild-to-moderate AD

Group Type EXPERIMENTAL

MRI

Intervention Type OTHER

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

FDG-PET

Intervention Type 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

Cognitively Normal Elderly Participants

Elderly participants with no cognitive impairment

Group Type EXPERIMENTAL

MRI

Intervention Type OTHER

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

FDG-PET

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MRI

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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes