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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 2

Conditions

Alzheimer's Disease

Treatments

Drug: Comparator: Placebo (unspecified)

Drug: MK0249

Study type

Interventional

Funder types

Industry

Identifiers

NCT00420420

2006_534

0249-011

Details and patient eligibility

About

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.

Enrollment

144 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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