MK0249 for the Symptomatic Treatment of Alzheimer's Disease (MK0249-011)

NCT ID: NCT00420420

Last Updated: 2015-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2008-08-31

Brief Summary

The purpose of this study is to test the efficacy and safety of an investigational medication for improving symptoms of Alzheimer's Disease. Subjects will receive either active medication or placebo for 28 days. Tests of memory, concentration will be included. Safety will be monitored using routine clinical and laboratory tests.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MK0249

Group Type: EXPERIMENTAL

MK0249

Intervention Type: DRUG

MK0249 two (2) 2.5 mg capsules quaque die (qd) for 28 day treatment period.

placebo

Group Type: PLACEBO_COMPARATOR

Comparator: Placebo (unspecified)

Intervention Type: DRUG

MK0249 two (2) 2.5 mg Pbo capsules qd for a 28 day treatment period

Interventions

MK0249

MK0249 two (2) 2.5 mg capsules quaque die (qd) for 28 day treatment period.

Intervention Type: DRUG

Comparator: Placebo (unspecified)

MK0249 two (2) 2.5 mg Pbo capsules qd for a 28 day treatment period

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or females
• Age at least 55 years or older
• Mild-to-moderate Alzheimer's Disease, with Mini Mental State Examination (MMSE) between 18 and 26, inclusive, Modified Hachinski Ischemic Scale (MHIS) score =/<4, Global CDR score of 1 or 2, and who have a reliable informant/caregiver to accompany patient to all clinic visits
• If using symptomatic Alzheimer's Disease treatments, patients must be on the medication for 3 months and on a STABLE DOSE for at least 2 months

Exclusion Criteria

• Patients cannot be living in a skilled nursing facility
• Patients cannot have poorly-controlled hypertension
• Patients cannot have the following conditions within 6 months of screening: significant cardiovascular disorders, active major depressive disorder, gastroesophageal reflux disease (GERD), or clinically significant sleep disorder
• Various concomitant therapy restrictions

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Egan M, Yaari R, Liu L, Ryan M, Peng Y, Lines C, Michelson D. Pilot randomized controlled study of a histamine receptor inverse agonist in the symptomatic treatment of AD. Curr Alzheimer Res. 2012 May;9(4):481-90. doi: 10.2174/156720512800492530.

Reference Type: RESULT

PMID: 22272611 (View on PubMed)

Other Identifiers

2006_534

Identifier Type: -

Identifier Source: secondary_id

0249-011

Identifier Type: -

Identifier Source: org_study_id