Alzheimer's DiseasePhase 1NCT00777608

A Study to Test the Performance of the CogState Computerized Neuropsychological Battery in Patients With Alzheimer's Disease (0000-086)(COMPLETED)

A Phase 1 study testing Donepezil 5 - 10 mg and Donepezil 10 mg 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.

Official record

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Trial summary

This study will evaluate the performance of the CogState computerized neuropsychological battery, Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) and Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) in participants with mild-to-moderate Alzheimer's disease (AD). 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?: Donepezil 5 - 10 mg and Donepezil 10 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 106 participants
Where: No sites listed yet
Study dates: Dec 2008to Apr 2010
Phase: Phase 1
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

Participant is ambulatory, male or female and 55 years of age or older
Participant has reliable informant/caregiver who can communicate effectively with the study site and personnel

Who cannot join

Participant has a history within the last 6 months or current evidence of a psychotic disorder or an active major depressive disorder or participant has any history of schizophrenia
Participant has a history of multiple and/or serious allergies to drugs or food or a history of an allergic reaction to more than 3 drug classes

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial, With Placebo Run-In, and an Open-Label Treatment Period, to Evaluate the Performance of the CogState Computerized Neuropsychological Battery and the ADAS-Cog in Generally Cholinesterase-naive AD Patients

Conditions: Alzheimer's Disease
Being tested: Comparator: Placebo 5mg (run in), Donepezil 5 - 10 mg, Comparator: Placebo 5-10 mg, Donepezil 10 mg
Medical subject headings: Alzheimer Disease

What participants receive

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

Comparator: Placebo 5mg (run in)Drug
Matching placebo to donepezil - 5 mg capsules orally for 14 day run in prior to randomization.
Donepezil 5 - 10 mgDrug
Donepezil 1 capsule (5 mg) orally, once daily for 14 days.
Donepezil 2 capsules (total 10 mg) once daily for 70 days (days 15-84).
Comparator: Placebo 5-10 mgDrug
Matching placebo to donepezil, 1 capsule (5 mg) orally, once daily for 14 days.
Matching placebo to donepezil 2 capsules (total 10 mg) once daily for 70 days (days 15-84).
Donepezil 10 mgDrug
Donepezil 2 capsules (total 10 mg) orally, once daily for 24 weeks, from day 85 (optional).

Study groups in NCT00777608
Study group	Role	What they receive
Donepezil 5-10 mg	Experimental	There will be a 14 day period when all participants will receive placebo, followed by 5 mg donepezil, once daily for 14 days then titrated to 10 mg donepezil once daily for 70 days. Participants may then receive open-label donepezil for an additional 24 weeks. Receives: Drug: Comparator: Placebo 5mg (run in); Drug: Donepezil 5 - 10 mg; Drug: Donepezil 10 mg
Placebo	Placebo comparator	There will be a 14 day period when all participants will receive placebo. Participants will take placebo capsules orally, once daily for 84 days. Participants may then receive open-label donepezil for an additional 24 weeks. Receives: Drug: Comparator: Placebo 5mg (run in); Drug: Comparator: Placebo 5-10 mg; Drug: Donepezil 10 mg

What is being measured

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

Change in Mean Computer-based Cognitive Assessment (CogState) Composite Score at Week 4
CogState is a simple, brief computerized neuropsychological battery to evaluate cognitive impairments characterizing mild-to-moderate Alzheimer's Disease (AD). The composite CogState assesses attention and memory functions - including Verbal episodic memory, Visual Episodic Memory, Psychomotor function, Visual attention and working memory. CogState scores are measured on a linear scale (with no maximum score) and a reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change in the CogState Composite Score at Week 4 compared to baseline.
Measured: Baseline and 4 weeks

Secondary outcomes (2)

Evaluate the Efficacy of Donepezil by Determining the Change in Mean CogState Composite Score at Week 2, Week 8 and Week 12
CogState is a simple, brief computerized neuropsychological battery to evaluate cognitive impairments characterizing mild-to-moderate Alzheimer's Disease (AD). The composite CogState assesses attention and memory functions - including Verbal episodic memory, Visual Episodic Memory, Psychomotor function, Visual attention and working memory. CogState scores are measured on a linear scale (no maximum score) and a reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change from baseline in the CogState Composite Score at Weeks 4, 8 and 12.
Measured: Baseline and 2 weeks, 8 weeks and 12 weeks
Evaluate the Efficacy of Donepezil by Determining the Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score at Week 4, Week 8 and Week 12
The ADAS-Cog is a psychometric instrument that evaluates memory, attention,
reasoning, language, orientation and praxis using an 11-point AD Assessment Scale. It has a minimum score of 0 and a maximum severity score of 70, and a higher score indicates more impairment. A reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change in the ADAS-Cog score at Weeks 4, 8 and 12 compared to baseline.
Measured: Baseline and 4 weeks, 8 weeks and 12 weeks.

Timeline

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

Dec 2008Apr 2010

First posted22 Oct 2008 (estimated)
Study startDec 2008
Primary completionOct 2009
Study completionApr 2010

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.
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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00777608
Sponsor's protocol ID: 0000-086
Other IDs: 2008_573
Status last verified: Aug 2015
First submitted: 21 Oct 2008
Last updated: 25 Aug 2015
Results posted: Yes, on ClinicalTrials.gov

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 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial, With Placebo Run-In, and an Open-Label Treatment Period, to Evaluate the Performance of the CogState Computerized Neuropsychological Battery and the ADAS-Cog in Generally Cholinesterase-naive AD Patients
ClinicalTrials.gov ID: NCT00777608
Acronym / sponsor ID: 0000-086
Conditions: Alzheimer's Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: Oct 2009 (actual)
Study completion: Apr 2010 (actual)
First posted: 22 Oct 2008 (estimated)
Results: Posted 24 Feb 2011

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
Donepezil 5-10 mg	Experimental	Drug: Comparator: Placebo 5mg (run in), Drug: Donepezil 5 - 10 mg, Drug: Donepezil 10 mgThere will be a 14 day period when all participants will receive placebo, followed by 5 mg donepezil, once daily for 14 days then titrated to 10 mg donepezil once daily for 70 days. Participants may then receive open-label donepezil for an additional 24 weeks.
Placebo	Placebo comparator	Drug: Comparator: Placebo 5mg (run in), Drug: Comparator: Placebo 5-10 mg, Drug: Donepezil 10 mgThere will be a 14 day period when all participants will receive placebo. Participants will take placebo capsules orally, once daily for 84 days. Participants may then receive open-label donepezil for an additional 24 weeks.

Who may qualify

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

Key inclusion criteria (2 listed)

Participant is ambulatory, male or female and 55 years of age or older
Participant has reliable informant/caregiver who can communicate effectively with the study site and personnel

Key exclusion criteria (2 listed)

Participant has a history within the last 6 months or current evidence of a psychotic disorder or an active major depressive disorder or participant has any history of schizophrenia
Participant has a history of multiple and/or serious allergies to drugs or food or a history of an allergic reaction to more than 3 drug classes

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
Comparator: Placebo 5mg (run in)Matching placebo to donepezil - 5 mg capsules orally for 14 day run in prior to randomization.	Drug	Donepezil 5-10 mg, Placebo
Donepezil 5 - 10 mgDonepezil 1 capsule (5 mg) orally, once daily for 14 days. Donepezil 2 capsules (total 10 mg) once daily for 70 days (days 15-84).	Drug	Donepezil 5-10 mg
Comparator: Placebo 5-10 mgMatching placebo to donepezil, 1 capsule (5 mg) orally, once daily for 14 days. Matching placebo to donepezil 2 capsules (total 10 mg) once daily for 70 days (days 15-84).	Drug	Placebo
Donepezil 10 mgDonepezil 2 capsules (total 10 mg) orally, once daily for 24 weeks, from day 85 (optional).	Drug	Donepezil 5-10 mg, Placebo

Primary outcome

Change in Mean Computer-based Cognitive Assessment (CogState) Composite Score at Week 4
Time frame: Baseline and 4 weeks
CogState is a simple, brief computerized neuropsychological battery to evaluate cognitive impairments characterizing mild-to-moderate Alzheimer's Disease (AD). The composite CogState assesses attention and memory functions - including Verbal episodic memory, Visual Episodic Memory, Psychomotor function, Visual attention and working memory. CogState scores are measured on a linear scale (with no maximum score) and a reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change in the CogState Composite Score at Week 4 compared to baseline.

2 secondary outcomes

Evaluate the Efficacy of Donepezil by Determining the Change in Mean CogState Composite Score at Week 2, Week 8 and Week 12
Time frame: Baseline and 2 weeks, 8 weeks and 12 weeks
Evaluate the Efficacy of Donepezil by Determining the Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score at Week 4, Week 8 and Week 12
Time frame: Baseline and 4 weeks, 8 weeks and 12 weeks.

Results and safety

Results posted to the registry on 24 Feb 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Donepezil 5-10 mg	53	49
Placebo	53	47

Primary outcome: Change in Mean Computer-based Cognitive Assessment (CogState) Composite Score at Week 4

Time frame: Baseline and 4 weeks. Least squares mean (Standard Error). Unit: Score on a scale

Measure	Donepezil 5-10 mg n = 38	Placebo n = 43
Value	-0.10 (0.07)	-0.07 (0.06)

Donepezil 5-10 mg vs Placebo: Mean Difference (Final Values): -0.07 (90% CI -0.2 to 0.08), p = 0.231, ANOVA

Population analysed: The analysis for the primary and secondary CogState endpoints was done on a per protocol basis (only participants who were compliant and successfully tolerated the forced titration after 2 weeks of treatment were included in the analysis).

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Donezepil 5-10 mg	3 of 53 (5.7%)	10 of 53 (18.9%)	Not reported
Placebo	0 of 53 (0%)	9 of 53 (17%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Enrolling by invitationPhase 2
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Primary Care Detection of Cognitive Impairment Leveraging Health & Consumer Technologies in Underserved Communities: The MyCog Trial
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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 1 study testing Donepezil 5 - 10 mg and Donepezil 10 mg 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 2 inclusion and 2 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 25 Aug 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 24 Feb 2011). 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?

Change in Mean Computer-based Cognitive Assessment (CogState) Composite Score at Week 4 (time frame: Baseline and 4 weeks). 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 NCT00777608.

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 25 Aug 2015.