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

NCT00420420 | Completed Phase 2 Results

• 2 other identifiers: 0249-0112006_534
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

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

  The CNTB was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the short CNTB summary score. The short CNTB summary score was scored as the mean score across 5 modules: Word List Learning-Selective Reminding, Word List Learning-Delayed Recall, Simple Reaction Time, Choice Reaction Time, and Visual Memory subtests. The short CNTB summary score ranges from 0 to 100, with higher scores (and positive changes from baseline) indicating better performance.

  Baseline and Week 4

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

  The ADAS-Cog, scored as the total score of 11 tasks including mazes was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the ADAS-Cog total score. The ADAS-Cog total score ranges from 0 to 70, with higher total scores indicating more impairment. Lower scores (and negative changes from Baseline) indicate better performance.

  Baseline and Week 4

Secondary Outcomes (1)

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

  Baseline and Week 4

Other Outcomes (3)

• Baseline: Short CNTB Summary Score.

  Baseline

• Baseline: ADAS-Cog Total Score

  Baseline

• Baseline: Cognition Summary Score (CSS)

  Baseline

Study Arms (2)

MK0249

EXPERIMENTAL

Drug: MK0249

placebo

PLACEBO COMPARATOR

Drug: Comparator: Placebo (unspecified)

Interventions

MK0249 DRUG

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

MK0249

Comparator: Placebo (unspecified) DRUG

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

placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 22272611 RESULT

MeSH Terms

Conditions

Alzheimer Disease

Interventions

MK-0249

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2007
• First Posted: January 11, 2007
• Study Start: November 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: February 12, 2015
• Results First Posted: November 18, 2010

Record last verified: 2015-01