NCT00362024

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_2

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

May 16, 2016

Status Verified

May 1, 2016

Enrollment Period

1 year

First QC Date

August 8, 2006

Last Update Submit

May 13, 2016

Conditions

Alzheimer's Disease

Interventions

MK0952DRUG
Comparator: PlaceboDRUG

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alzheimer Disease

Interventions

MK-0952

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2006

First Posted

August 9, 2006

Study Start

November 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

May 16, 2016

Record last verified: 2016-05