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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00362024
First received: August 8, 2006
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Alzheimer's Disease
Drug: MK0952
Drug: Comparator: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: MK0952 in Patients With Mild-to-Moderate Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Study Start Date: November 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: MK0952
    Other Name: MK0952
    Drug: Comparator: Placebo
  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362024

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00362024     History of Changes
Other Study ID Numbers: 0952-004, 2006_026
Study First Received: August 8, 2006
Last Updated: August 30, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014