Alzheimer's DiseasePhase 2NCT00420420

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

A Phase 2 study testing MK0249 in people with Alzheimer's Disease, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 55 years and older
Conditions the study is for: Alzheimer's Disease
What is being tested?: MK0249
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 144 participants
Where: No sites listed yet
Study dates: Nov 2006to Aug 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: 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

Conditions: Alzheimer's Disease
Being tested: MK0249, Comparator: Placebo (unspecified)
Medical subject headings: Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MK0249Drug
MK0249 two (2) 2.5 mg capsules quaque die (qd) for 28 day treatment period.
Comparator: Placebo (unspecified)Drug
MK0249 two (2) 2.5 mg Pbo capsules qd for a 28 day treatment period

Study groups in NCT00420420
Study group	Role	What they receive
MK0249	Experimental	Not described Receives: Drug: MK0249
placebo	Placebo comparator	Not described Receives: Drug: Comparator: Placebo (unspecified)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Baseline and Week 4

Secondary outcomes (1)

Week 4 Change From Baseline in Cognition Summary Score (CSS)
The CSS was used to evaluate cognitive function as measured by the mean change from Baseline to Week 4 in the CSS total score. The CSS was derived from the correct sequence percentage from the Route Test and 6 of the CNTB scores (the CSS was scored as the mean of the 7 scores). CSS scores can range from 0 to 100, higher scores (and positive changes from baseline) indicate better performance.
Measured: Baseline and Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2006Aug 2008

First posted11 Jan 2007 (estimated)
Study startNov 2006
Primary completionAug 2008
Study completionAug 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 144 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00420420
Sponsor's protocol ID: 0249-011
Other IDs: 2006_534
Status last verified: Jan 2015
First submitted: 9 Jan 2007
Last updated: 12 Feb 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 22272611

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Alzheimer's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00420420
Acronym / sponsor ID: 0249-011
Conditions: Alzheimer's Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 144 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Nov 2006
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 11 Jan 2007 (estimated)
Results: Posted 18 Nov 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
MK0249	Experimental	Drug: MK0249
placebo	Placebo comparator	Drug: Comparator: Placebo (unspecified)

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MK0249MK0249 two (2) 2.5 mg capsules quaque die (qd) for 28 day treatment period.	Drug	MK0249
Comparator: Placebo (unspecified)MK0249 two (2) 2.5 mg Pbo capsules qd for a 28 day treatment period	Drug	placebo

Primary outcome

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

1 secondary outcome

Week 4 Change From Baseline in Cognition Summary Score (CSS)
Time frame: Baseline and Week 4

Results and safety

Results posted to the registry on 18 Nov 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK0249 (5 mg)	73	65
Placebo	71	67

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

Time frame: Baseline and Week 4. Mean (Standard Error). Unit: units on a scale

Measure	MK0249 (5 mg) n = 59	Placebo n = 62
Value	0.13 (0.61)	-0.76 (0.57)

MK0249 (5 mg) vs Placebo: p = 0.283, Mixed Models Analysis

Population analysed: Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized.

Primary outcome: 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. Mean (Standard Error). Unit: units on a scale

Measure	MK0249 (5 mg) n = 70	Placebo n = 68
Value	-1.42 (0.50)	-1.17 (0.49)

MK0249 (5 mg) vs Placebo: p = 0.716, Mixed Models Analysis

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Patients were assessed for AEs from Visit 2 (Day 0) Baseline through Visit 8 (Day 43) Post-Study Safety Visit.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK0249 (5 mg)	3 of 73 (4.1%)	29 of 73 (39.7%)	Not reported
Placebo	1 of 70 (1.4%)	9 of 70 (12.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22272611Egan 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.

Related trials for Alzheimer's Disease

RecruitingPhase 2
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Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
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RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
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RecruitingPhase 3
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RecruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MK0249 in people with Alzheimer's Disease, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Week 4 Change From Baseline in Computerized Neuropsychological Test Battery (CNTB): Short CNTB Summary Score. (time frame: Baseline and Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00420420, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2015.