← Trials/Trial dossier/NCT05641480

UnknownPhase NA

Technical R&D and Demonstration of Intelligent Medical Care in Alzheimer's Disease's Management

Lead sponsor

Shaanxi Hospital of Traditional Chinese Medicine

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

150

estimated

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criterion

•SCD / MCI / mild dementia

Primary endpoints

•AD-seeds protein analyzer（Developed by Professor Jia Jianping of Capital•Or adopting Serum Aβ level is detected

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 ID2020ZDLSF04-03

NCT IDNCT05641480

Timeline

Milestones

Study start2022-06-03actual

Study first posted2022-12-07actual

Last update posted2022-12-13actual

Primary completion2025-12-09estimated

Study completion2025-12-09estimated

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age55 Years

Maximum age75 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Meeting the diagnostic criteria of SCD, MCI and mild dementia;

•Memory decline (self-reported or confirmed by both informants);

•Age 55-75 years;

•Memory impairment has not reached the diagnostic criteria of moderate and severe dementia;

•Hachinski ischemia scale score ≤ 4;

•Exclude any other systemic diseases that can cause brain dysfunction;

•Hamilton Depression Scale < 17;

•The subject or guardian signed the informed consent

Exclusion criteria

•There are advanced, serious or unstable other diseases, such as liver, kidney and other serious primary diseases;

•Severe hearing and visual impairment, can not cooperate with the assessment;

•with active epilepsy;

•Previous history of mental illness;

•Moderate or severe dementia, cerebral infarction or any physical or mental disorder that may lead to brain dysfunction;

•Having used other drugs that may cause cognitive function changes or heart, brain, kidney and other important organs failure before inclusion;

•Under 55 years old or above 75 years old;

•Unable to cooperate with the completion of the corresponding assessment and inspection and quit;

•Those who are likely to have poor compliance with the test;

•Participants in other subjects.

Endpoints (11)

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)

Global cognition

Amyloid biomarkers

Safety / tolerability / PK

Global cognition

2 endpoints

Secondary/protocol endpoint

Change of total MMSE score from baseline

Time frame:Change from Baseline at 6 months（FIve times：Week -1~0 day，Week 4 ± 2 days，week 8 ± 2 days，week 12 ± 3 days，week 24 ± 3 days）

Mini-Mental State Examination (MMSE)

categorical status, descriptive

Secondary/protocol endpoint

Montreal Cognitive Assessment Scale (MoCA) Score

Time frame:Change from Baseline at 6 months（FIve times：Week -1~0 day，Week 4 ± 2 days，week 8 ± 2 days，week 12 ± 3 days，week 24 ± 3 days）

Montreal Cognitive Assessment (MoCA)

descriptive

Amyloid biomarkers

1 endpoint

Primary/protocol endpoint

AD-seeds protein analyzer（Developed by Professor Jia Jianping of Capital Medical University of China）

Time frame:Change from Baseline Aβ level at 6 months

categorical status, descriptive

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Electrocardiogram（ECG）

Time frame:Change from Baseline at 6 months（Week -1~0 day, week 24 ± 3 days）

descriptive

Other (unclassified)

7 endpoints

Primary/protocol endpoint/low confidence

Or adopting Serum Aβ level is detected

Time frame:Change from Baseline Aβ level at 6 months

descriptive