MK0952 in Patients With Mild-to-Moderate Alzheimer's Disease (0952-004)(COMPLETED)

May 13, 2016 updated by: Merck Sharp & Dohme LLC

MK0952 in Patients With Mild-to-Moderate Alzheimer's Disease

MK0952 is a phosphodiesterase type IV (PDE4) inhibitor in development for improvement of cognitive impairment in mild-to-moderate Alzheimer's disease.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or females
  • Age >/= 55 years, With mild-to-moderate AD, with MMSE between 18 and 26, inclusive, MHIS score </= 4, Global CDR score of 1 or 2
  • Who have a reliable informant/caregiver to accompany patient to all clinic visits
  • If using a symptomatic AD treatments, patients must be on stable dose for >/= 6 months

Exclusion Criteria:

  • Patients must not be living in nursing home or skilled nursing facility
  • Patients must not have current evidence and/or history of Crohn's disease, ulcerative colitis, proctitis, GI bleeding, mesenteric arteritis
  • Patients must not have current evidence and/or history of poorly-controlled hypertension, clinically significant cardiac arrhythmia, angina, or CHF
  • Patients must not have current evidence and/or history of a psychotic disorder or major untreated depressive disorder
  • Patients must not have current evidence and/or history of stroke or multiple lacunar infarcts, or neurological or neurodegenerative disorder (other than AD)
  • Various concomitant therapy restrictions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (ACTUAL)

November 1, 2007

Study Completion (ACTUAL)

November 1, 2007

Study Registration Dates

First Submitted

August 8, 2006

First Submitted That Met QC Criteria

August 8, 2006

First Posted (ESTIMATE)

August 9, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 16, 2016

Last Update Submitted That Met QC Criteria

May 13, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0952-004
  • 2006_026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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