Status:

COMPLETED

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)

Lead Sponsor:

Merck Sharp & Dohme LLC

Conditions:

Alzheimer's Disease

Eligibility:

All Genders

55+ years

Phase:

PHASE1

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 b...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

September 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2010

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT00757939

Start Date

September 1 2008

End Date

October 1 2010

Last Update

August 11 2015

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