NCT00074529

Brief Summary

An investigational drug (MK0677) will be studied to determine whether it helps the memory and cognition of patients with Alzheimer's Disease.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
512

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2003

Status
completed

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

Study Start

First participant enrolled

October 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2003

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

July 24, 2015

Status Verified

July 1, 2015

Enrollment Period

2.3 years

First QC Date

December 15, 2003

Last Update Submit

July 23, 2015

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • Cognitive function over 12 month period; safety and tolerability

    over 12 month period

Secondary Outcomes (1)

  • AD symptoms over a 6 month and 12 month period measured by the CIBIC + and the ADAS-Cog.

    over a 6 month and 12 month period

Interventions

MK0677DRUG

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* Patients must have probable Alzheimer's disease of mild or moderate severity. * A brain scan and laboratory results must be consistent with Alzheimer's disease. * The patient must be otherwise medically healthy.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (2)

  • Sevigny JJ, Ryan JM, van Dyck CH, Peng Y, Lines CR, Nessly ML; MK-677 Protocol 30 Study Group. Growth hormone secretagogue MK-677: no clinical effect on AD progression in a randomized trial. Neurology. 2008 Nov 18;71(21):1702-8. doi: 10.1212/01.wnl.0000335163.88054.e7.

    PMID: 19015485BACKGROUND

  • Sevigny JJ, Peng Y, Liu L, Lines CR. Item analysis of ADAS-Cog: effect of baseline cognitive impairment in a clinical AD trial. Am J Alzheimers Dis Other Demen. 2010 Mar;25(2):119-24. doi: 10.1177/1533317509350298.

    PMID: 19949163DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

ibutamoren mesylate

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
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2003

First Posted

December 16, 2003

Study Start

October 1, 2003

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

July 24, 2015

Record last verified: 2015-07