ODESA

CompletedPhase 3

Optimal Dose Escalation Strategy to Successful Achievement of High Dose Donepezil 23mg

A Multicenter, Randomized, Open-label, Prospective Trial to Evaluate the Safety and Tolerability of Donepezil 23 mg With or Without Intermediate Dose Titration in Patients With Alzheimer's Disease Taking Donepezil Hydrochloride 10 mg

Lead sponsor

Asan Medical Center

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

176

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 20•Study partner/caregiver required•AD symptomatic therapy: stable ≥3 months

Primary endpoint

•Treatment-emergent adverse events

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDJHongLee

NCT IDNCT02550665

Timeline

Milestones

Study start2014-12actual (month precision)

Study first posted2015-09-15estimated

Primary completion2016-08actual (month precision)

Study completion2016-10actual (month precision)

Last update posted2018-08-07actual

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age45 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•dementia according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria

•probable Alzheimer's disease dementia according to National Institute on Aging-Alzheimer's Association (NIAAA) criteria

•Mini-Mental State Examination (MMSE) score of 20 or less

•General Deterioration Scale (GDS) score of 4 or more / Clinical Dementia Rating (CDR) score of 2 or more

•stable dose of 10mg donepezil at least 3 months before screening

•caregiver who can come together at every visit and give informations about side effects profiles should exist

•patients and caregivers accepted the study

Exclusion criteria

•patients receiving other concomitant acetylcholinesterase inhibitor

•uncontrolled psychiatric disorders

•drug overuse or alcohol abuse history within 5 years

•significant uncontrolled or active medical conditions

•uncontrolled epilepsy

•patients who cannot come at scheduled visits

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Incidence of treatment-emergent adverse events (safety and tolerability)

Time frame:Change from baseline at 4 week

event count, event