Alzheimer's DiseasePhase 2NCT02064920

Computerized Cognition Testing in Participants With Mild Alzheimer's Disease (AD) Treated With Donepezil (MK-0000-318)

A Phase 2 study testing Donepezil 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

This study aims to determine whether the Cogstate testing battery can detect improvements in cognitive function in participants with mild AD. The primary hypothesis is that for one of the Cogstate battery tests, One Card Learning (OCL), the standard deviation associated with the change from baseline in OCL… Read more about this study

Who is it for?: Ages 55 to 85 years
Conditions the study is for: Alzheimer's Disease
What is being tested?: Donepezil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: No sites listed yet
Study dates: 22 Apr 2014to 13 Jul 2016
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 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Meets listed criteria for a diagnosis of probable AD
Has a clearly documented history either in medical records or from an informant of cognitive decline over at least 6 months
Has a reliable partner/caregiver who is willing to provide input by participating in assessments
Has results of a physical examination and clinical laboratory tests within normal or clinically acceptable limits
Can communicate with trial staff acceptably, possesses the ability to respond verbally to questions, follow instructions, complete questionnaires, and adhere to visit schedules
Can read at a 9th grade level or equivalent, and has an acceptable history of academic achievement and/or employment

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Has a magnetic resonance imaging (MRI) scan that rules out non-AD conditions contributing to cognitive dysfunction
Capably performs the CogState screening battery
Has adequate visual acuity and function
Females are not of childbearing potential

Who cannot join

Has ever received acetylcholinesterase inhibitors, memantine, or other symptomatic AD treatment including approved medical foods
Has an uncontrolled, clinically significant medical condition or situation within 3 months prior to screening
Has had major surgery within 3 months prior to screening
Has tested positive for human immunodeficiency virus (HIV) or has evidence of an active hepatitis B infection
Has a history of malignancy within the prior 5 years
Is unwilling or ineligible to undergo an MRI scan

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Has a history of clinically important structural changes on screening MRI scan
Has a clinically important history of stroke or a diagnosis of vascular dementia
Has evidence of a clinically relevant non-AD neurological disorder
Has a history of head trauma, or serious infectious disease affecting the brain within the prior 3-5 years
Has evidence of a clinically relevant or unstable psychiatric disorder, excepting major depression in remission
Has evidence of a current episode of major depression
Has evidence of Type 4 or Type 5 Suicidal Ideation
Has clinically significant vitamin B12 or folate deficiency in the 6 months prior to screening
Is pregnant, attempting to become pregnant or is nursing children
Has used any investigational drug or participated in any other clinical trial within the prior 30 days
Has a history of alcoholism or drug dependency/abuse within the last 5 years
Has a relative contraindication to donepezil including sick sinus syndrome, third degree heart block, active gastrointestinal (GI) bleeding, Zollinger-Ellison syndrome, uncontrolled peptic ulcer disease, or uncontrolled asthma

About this study

Official title: A Clinical Trial to Assess Cognitive Function by Repeated Computerized Testing in Patients With Mild Alzheimer's Disease Treated With Donepezil

Conditions: Alzheimer's Disease
Being tested: Placebo, Donepezil
Medical subject headings: Alzheimer Disease

What participants receive

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

PlaceboDrug
Placebo for donepezil hydrochloride capsule
DonepezilDrug
Also called Aricept
5 mg donepezil hydrochloride capsule.
DonepezilDrug
Also called Aricept
10 mg donepezil hydrochloride capsule.

Study groups in NCT02064920
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks. Receives: Drug: Placebo
Donepezil	Experimental	During the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability. Receives: Drug: Placebo; Drug: Donepezil

What is being measured

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

One-card Learning (OCL) Measurement Over 12 Weeks of Treatment
OCL is one of the Cogstate battery of tests, and is a continuous visual recognition task that assesses visual recognition, memory and attention using a pattern separation algorithm. OCL is a score defined as the arcsine transformation of the square root of the proportion of correct responses to 80 OCL questions. The score ranges from 0 to 1.5708 where a higher score means better performance.
Measured: Weeks 4, 8, 12 and 16

Secondary outcomes (1)

Percentage of Correct Responses in the OCL Task Over 12 Weeks of Treatment
OCL is one of the Cogstate battery of tests, and is a continuous visual recognition task that assesses visual recognition, memory and attention using a pattern separation algorithm. The percentage of correct responses to 80 OCL questions is defined as the number of correct responses x 100 divided by the number of total responses; and ranges from 0 to 100, where 100 is best, and 0 is the worst outcome.
Measured: Weeks 4, 8, 12 and 16

Timeline

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

22 Apr 201413 Jul 2016

First posted17 Feb 2014 (estimated)
Study start22 Apr 2014
Primary completion13 Jul 2016
Study completion13 Jul 2016

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 2
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02064920
Sponsor's protocol ID: 0000-318
Status last verified: Sep 2018
First submitted: 14 Feb 2014
Last updated: 12 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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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Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Trial to Assess Cognitive Function by Repeated Computerized Testing in Patients With Mild Alzheimer's Disease Treated With Donepezil
ClinicalTrials.gov ID: NCT02064920
Acronym / sponsor ID: 0000-318
Conditions: Alzheimer's Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 22 Apr 2014 (actual)
Primary completion: 13 Jul 2016 (actual)
Study completion: 13 Jul 2016 (actual)
First posted: 17 Feb 2014 (estimated)
Results: Posted 1 Aug 2017

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: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPlacebo for donepezil hydrochloride capsule administered orally once a day for 16 weeks.
Donepezil	Experimental	Drug: Placebo, Drug: DonepezilDuring the first 4 weeks, participants received placebo for donepezil. Over the following 2 weeks, participants were treated with donepezil at 5 mg per day. Then, over the remaining 10 weeks were titrated to up to 10 mg per day donepezil based on tolerability.

Who may qualify

Ages: 55 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Meets listed criteria for a diagnosis of probable AD
Has a clearly documented history either in medical records or from an informant of cognitive decline over at least 6 months
Has a reliable partner/caregiver who is willing to provide input by participating in assessments
Has results of a physical examination and clinical laboratory tests within normal or clinically acceptable limits
Can communicate with trial staff acceptably, possesses the ability to respond verbally to questions, follow instructions, complete questionnaires, and adhere to visit schedules

Key exclusion criteria (18 listed)

Has ever received acetylcholinesterase inhibitors, memantine, or other symptomatic AD treatment including approved medical foods
Has an uncontrolled, clinically significant medical condition or situation within 3 months prior to screening
Has had major surgery within 3 months prior to screening
Has tested positive for human immunodeficiency virus (HIV) or has evidence of an active hepatitis B infection
Has a history of malignancy within the prior 5 years

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
PlaceboPlacebo for donepezil hydrochloride capsule	Drug	Donepezil, Placebo
DonepezilAlso: Aricept5 mg donepezil hydrochloride capsule.	Drug	Donepezil
DonepezilAlso: Aricept10 mg donepezil hydrochloride capsule.	Drug	Donepezil

Primary outcome

One-card Learning (OCL) Measurement Over 12 Weeks of Treatment
Time frame: Weeks 4, 8, 12 and 16
OCL is one of the Cogstate battery of tests, and is a continuous visual recognition task that assesses visual recognition, memory and attention using a pattern separation algorithm. OCL is a score defined as the arcsine transformation of the square root of the proportion of correct responses to 80 OCL questions. The score ranges from 0 to 1.5708 where a higher score means better performance.

1 secondary outcome

Percentage of Correct Responses in the OCL Task Over 12 Weeks of Treatment
Time frame: Weeks 4, 8, 12 and 16

Results and safety

Results posted to the registry on 1 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	6	5
Donepezil	30	21

Primary outcome: One-card Learning (OCL) Measurement Over 12 Weeks of Treatment

Time frame: Weeks 4, 8, 12 and 16. Mean (Standard Deviation). Unit: Score on a scale

Measure	Placebo n = 5	Donepezil n = 28
Week 4 (n = 5, 28)	0.954 (0.091)	0.942 (0.112)
Week 8 (n = 5, 22)	0.822 (0.179)	0.969 (0.104)
Week 12 (n = 5, 21)	0.849 (0.132)	0.984 (0.118)
Week 16 (n = 5, 21)	0.961 (0.123)	0.993 (0.112)

Placebo vs Donepezil: Change in SD from Week 4 to Week 16: 0.005 (95% CI -0.031 to 0.039)

Population analysed: All participants who received study medication and yielded at least one measurement for that endpoint.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to Week 18 (approximately up to 129 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 6 (0%)	3 of 6 (50%)	Not reported
Donepezil	1 of 28 (3.6%)	9 of 28 (32.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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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 Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Donepezil 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 10 inclusion and 18 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 Oct 2018. 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 1 Aug 2017). 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?

One-card Learning (OCL) Measurement Over 12 Weeks of Treatment (time frame: Weeks 4, 8, 12 and 16). 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 NCT02064920.

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 Oct 2018.