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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04730635




Registration number
NCT04730635
Ethics application status
Date submitted
26/01/2021
Date registered
29/01/2021

Titles & IDs
Public title
Cognition Platform Study in Participants at Risk for Alzheimer's Disease (AD) (MK-0000-413)
Scientific title
A Clinical Study to Evaluate a Cognitive Platform to Support Development of Symptomatic Therapies in Participants at Risk for Alzheimer's Disease
Secondary ID [1] 0 0
MK-0000-413
Secondary ID [2] 0 0
0000-413
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Mild Cognitive Impairment 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Donepezil
Treatment: Drugs - Placebo

Experimental: Donepezil - Participants receive donepezil in doses up to 10 mg once daily (QD), orally in a scheduled titration for Days 1-56. The total treatment duration is 56 days.

Placebo comparator: Placebo - Participants receive placebo QD, orally for Days 1-56. The total treatment duration is 56 Days.


Treatment: Drugs: Donepezil
Donepezil 5 mg capsules for a total daily dose of up to 10 mg QD, orally, for Days 1-56.

Treatment: Drugs: Placebo
Dose matched placebo capsule QD, orally for Days 1-56.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Averaged Correct Response Rate on the One Card Learning Task to Week 8
Timepoint [1] 0 0
Baseline, Up to Week 8
Secondary outcome [1] 0 0
Change From Baseline in Standard Deviation for Averaged Correct Response Rate on the OCL Task (Arcsine Square Root Transformed) to Week 8
Timepoint [1] 0 0
Baseline, Up to Week 8
Secondary outcome [2] 0 0
Change From Baseline in Averaged Correct Response Rate on the OCL Task to Week 8 in Participants Receiving Donepezil
Timepoint [2] 0 0
Baseline, Up to Week 8

Eligibility
Key inclusion criteria
* Has an Mini Mental State Examination (MMSE) score between 18 and 28 (inclusive) at Screening (Visit 1) and Baseline (Visit 2)
* Has a diagnosis of mild cognitive impairment (MCI) or mild Alzheimer's Disease (AD)
* Has an Modified Hachinski Ischemia Scale (MHIS) score of =4
* Must have a reliable and competent study partner/informant who accompanies participant to study visits and participates in assessments
* Be willing to provide a blood sample for Apolipoprotein E (APOE) genotyping
* Does not have intellectual disability
* Be able to speak, read, hear, and understand the language of the study staff and the Informed Consent Form (ICF)
* Be able and willing to adhere to the study visit schedule
* Have visual acuity, visual function, hearing, and gross and fine motor skills adequate to support study participation
* Be capable of performing the Cogstate battery assessments, as demonstrated at the Baseline/Familiarization Visit (Visit 2)
* A female participant is eligible to participate if she is a woman of nonchildbearing potential (WONCBP)
Minimum age
55 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Is at imminent risk of self-harm
* Has evidence of a clinically relevant neurological disorder other than AD at screening, including but not limited to: Parkinson's disease, frontotemporal dementia, Huntington's disease, amyotrophic lateral sclerosis, multiple sclerosis, progressive supranuclear palsy, dementia with Lewy bodies, other types of dementia, neurosyphilis or that led to persistent cognitive deficits, or has a history of seizures or epilepsy within the last 5 years before screening
* Has a known history of stroke or has a diagnosis of vascular dementia
* Has history of multiple episodes of head trauma, or head trauma resulting in protracted loss of consciousness, or serious infectious disease affecting the brain, within the prior 3-5 years
* Has evidence of a clinically relevant or unstable psychiatric disorder, based on Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), including schizophrenia or other psychotic disorder, bipolar disorder, major depression, or delirium
* Has a recent or ongoing, uncontrolled, clinically significant medical condition within 2 months of the Screening visit
* Has a history of cancer
* Has a relative contraindication to donepezil including sick sinus syndrome, first, second, or third-degree heart block, bradycardia, active gastrointestinal (GI) bleeding, Zollinger-Ellison syndrome, uncontrolled peptic ulcer disease, or uncontrolled asthma
* Has a history of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food. Exception: Participants with selected allergies may be enrolled with Sponsor's approval
* Is positive for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV) [participants with a history of chronic hepatitis C virus with a documented cure and/or a positive serologic test for HCV with a negative HCV viral load may be included]
* Has clinically significant vitamin B12 or folate deficiency in the 6 months immediately before screening, or vitamin B12 or folate deficiency in addition to increased serum homocysteine and methylmalonic acid levels at screening
* Has prior AD treatment
* Has participated in another investigational study within 4 weeks
* Has a known history of structural changes on screening magnetic resonance imaging (MRI) scan that are clinically important, including signs indicative of vascular dementia, large infarct, lacunes in critical areas, space-occupying lesions, or extensive white matter disease
* Is unwilling to or not eligible to undergo a MRI scan (if a prior MRI scan is not available)
* Is pregnant, is attempting to become pregnant, or is nursing children
* Has a history of alcoholism or drug dependency/abuse within the last 5 years prior to the Screening visit
* Consumes greater than 3 glasses of alcoholic beverages per day
* Consumes excessive amounts, defined as greater than 6 servings of coffee, tea, cola, energy drinks, or other caffeinated beverages per day
* Is a regular user of cannabis, any illicit drugs or has a history of drug abuse within approximately 5 years. A participant who is a recreational user of cannabis or other drugs within the past 2 years can be enrolled as long as recreational use does not meet the definition of drug abuse and participant agrees to refrain from substance use for duration of study participation
* Participants must have a negative urine drug screen (UDS) prior to randomization
* Had major surgery within 3 months prior to the Screening visit that would interfere in the participant's ability to fully participate in the study
* Has undergone neuropsychological testing (including the MMSE) or cognitive remediation in the past 4 weeks
* Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/02/2023
Sample size
Target
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital-CALHN Memory Trials ( Site 0031) - Adelaide
Recruitment hospital [2] 0 0
Austin Health ( Site 0030) - Heidelberg
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04730635