Study of MK0677 for the Treatment of Alzheimer's Disease (0677-030)(COMPLETED)

Alzheimer's Disease Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of MK-0677 25 mg in Slowing the Progression of Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00074529
• Other study ID #: 0677-030
• Secondary ID: Formally-BG0812A
• Status: Completed
• Phase: Phase 2
• First received: December 15, 2003
• Last updated: July 23, 2015
• Start date: October 2003
• Est. completion date: January 2006

Study information

• Verified date: July 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 512
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• MK0677

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive function over 12 month period; safety and tolerability		over 12 month period	Yes
Secondary	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	No