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CompletedPhase 2Results posted

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

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety and Efficacy of MK0249 for the Symptomatic Treatment of Alzheimer's Disease

Lead sponsor

Merck Sharp & Dohme LLC

Asset

MK-0249

Listed sites

Recruiting sites

Enrollment

144

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•CDR global 1•MMSE 18-26•Study partner/caregiver required•AD symptomatic therapy: stable ≥2 months

Primary endpoints

•Week 4 Change From Baseline in Computerized Neuropsychological Test Battery•ADAS-Cog

Identifiers

Registered as

Org study ID0249-011

Secondary2006_534

NCT IDNCT00420420

Timeline

Milestones

Study start2006-11 (month precision)

Study first posted2007-01-11estimated

Primary completion2008-08actual (month precision)

Study completion2008-08actual (month precision)

Results first posted2010-11-18estimated

Last update posted2015-02-12estimated

Assets

Drug assets

MK-0249

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Global cognition

12 endpoints

Primary/protocol endpoint

Week 4 Change From Baseline in Computerized Neuropsychological Test Battery (CNTB): Short CNTB Summary Score.

Time frame:Baseline and Week 4

change from baseline, improvement

Primary/protocol endpoint

Week 4 Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog): ADAS-Cog Total Score

Time frame:Baseline and Week 4

ADAS-Cog

change from baseline, improvement

Primary/registry result

Week 4 Change From Baseline in Computerized Neuropsychological Test Battery (CNTB): Short CNTB Summary Score.

Time frame:Baseline and Week 4

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard error
MK0249 (5 mg)n=59 Participants	0.13	0.61
Placebon=62 Participants	-0.76	0.57

p0.283Mixed Models Analysis

comparison at Week 4

Primary/registry result

Week 4 Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog): ADAS-Cog Total Score

Time frame:Baseline and Week 4

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard error
MK0249 (5 mg)n=70 Participants	-1.42	0.50
Placebon=68 Participants	-1.17	0.49

p0.716Mixed Models Analysis

comparison at Week 4

Secondary/protocol endpoint

Week 4 Change From Baseline in Cognition Summary Score (CSS)

Time frame:Baseline and Week 4

change from baseline, improvement

Secondary/registry result

Week 4 Change From Baseline in Cognition Summary Score (CSS)

Time frame:Baseline and Week 4

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard error
MK0249 (5 mg)n=49 Participants	1.19	0.75
Placebon=51 Participants	-0.19	0.72

p0.180Mixed Models Analysis

comparison at week 4

Other/protocol endpoint

Baseline: Short CNTB Summary Score.

Time frame:Baseline

change from baseline, improvement

Other/protocol endpoint

Baseline: ADAS-Cog Total Score

Time frame:Baseline

ADAS-Cog

change from baseline, improvement

Other/protocol endpoint

Baseline: Cognition Summary Score (CSS)

Time frame:Baseline

change from baseline, improvement

Other_pre_specified/registry result

Baseline: Short CNTB Summary Score.

Time frame:Baseline

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
MK0249 (5 mg)n=64 Participants	35.98	5.72
Placebon=68 Participants	36.23	6.59

Other_pre_specified/registry result

Baseline: ADAS-Cog Total Score

Time frame:Baseline

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
MK0249 (5 mg)n=73 Participants	19.08	7.51
Placebon=70 Participants	18.42	7.32

Other_pre_specified/registry result

Baseline: Cognition Summary Score (CSS)

Time frame:Baseline

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
MK0249 (5 mg)n=56 Participants	42.31	7.35
Placebon=57 Participants	43.79	7.32

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.
PMID22272611via RESULT

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.