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

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ClinicalTrials.gov Identifier: NCT00362024
Recruitment Status : Terminated
First Posted : August 9, 2006
Last Update Posted : May 16, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE August 8, 2006
First Posted Date  ICMJE August 9, 2006
Last Update Posted Date May 16, 2016
Study Start Date  ICMJE November 2006
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE
 (submitted: August 8, 2006)
Proprietary Information - Exploratory (Non-Confirmatory) Trial
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2006)
Proprietary Information - Exploratory (Non-Confirmatory) Trial
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MK0952 in Patients With Mild-to-Moderate Alzheimer's Disease (0952-004)(COMPLETED)
Official Title  ICMJE MK0952 in Patients With Mild-to-Moderate Alzheimer's Disease
Brief Summary MK0952 is a phosphodiesterase type IV (PDE4) inhibitor in development for improvement of cognitive impairment in mild-to-moderate Alzheimer's disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: MK0952
  • Drug: Comparator: Placebo
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 13, 2016)
24
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries South Africa,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT00362024
Other Study ID Numbers  ICMJE 0952-004
2006_026
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP