Completed

DL-3-n-butylphthalide Treatment in Patients With Mild to Moderate Alzheimer's Disease Already Receiving Donepezil

DL-3-n-butylphthalide Treatment in Patients With Mild to Moderate Alzheimer's Disease Already Receiving Donepezil : A Multi Center, Prospective Cohort Stud

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Assets

Butylphthalide / Donepezil

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 11-22•Study partner/caregiver required

Primary endpoint

•ADAS-Cog

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

NCT IDNCT02711683

Org study IDXJTU1AF-CRF-2015-027

Timeline

Milestones

Study start2016-03actual (month precision)

Study first posted2016-03-17estimated

Primary completion2019-12actual (month precision)

Study completion2019-12actual (month precision)

Last update posted2020-02-12actual

Assets

Drug assets

Butylphthalide Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•literate Chinese, aged 50-85 years, with a consistent caregiver who accompanied the subjects at least 4 days a week，2 hours a day;

•complaint and/or informant report of cognitive impairment involving memory and/or other cognitive domains lasting for at least 12 months; and progressing gradually.

•diagnosis of probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria;

•a mini-mental state examination (MMSE) score ≥11 and ≤22 (primary school) or ≥11 and ≤26 (junior school or above) ;

•Hachinski ischemia scale score ≤4;

•All patients meeting the clinical criteria underwent brain magnetic resonance imaging (MRI) scan including hippocampal assessment at screening. The MRI entry criteria are as follows: the number of cerebral infarcts (≥20 mm in diameter)less than 2, without infarcts in thalamus, hippocampal or entorhinal cortex, the medial temporal lobe atrophy visual rating scale (MTA) score more than 2 degree.

•absent of neurological sign;

•having used donepezil more than 3 months and remained relatively stable；

•sign the informed consent

Exclusion criteria

•severe white matter lesion(WML)(score ≥3 according to the Fazekas rating scale), the number of cerebral infarcts (≥20 mm in diameter)more than 2, with infarcts in the important sites, such as thalamus, hippocampal or entorhinal cortex;

•dementia due to other causes, such as vascular dementia, infection of central nervous system，dementia with Lewy body(DLB)，etc

•suffered from other neurological disease, such as stroke, Parkinson's disease, epilepsy；

•suffered from mental disorders, such as schizophrenia，bipolar disorder，severe depression, delirium;

•suffered from unstable or severe disorders of heart, lung, liver, kidney and blood system;

•Severe impairment of vision and hearing;

•Using other cholinesterase inhibitors or memantine.

Endpoints (4)

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

Global cognition

Function / daily living

Behavior / neuropsychiatric

Caregiver / quality of life

Global cognition

1 endpoint

Primary/protocol endpoint

Alzheimer's disease assessment scale-cognitive subscale (ADAS-cog)

Time frame:Baseline, 48 weeks

ADAS-Cog

descriptive

Function / daily living

1 endpoint

Secondary/protocol endpoint

Alzheimer's Disease Cooperative Study-Activities of Daily Living(ADCS-ADL)

Time frame:Baseline, 48 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Neuropsychiatric Inventory(NPI)

Time frame:Baseline, 48 weeks

Neuropsychiatric Inventory (NPI)

descriptive

Caregiver / quality of life

1 endpoint

Secondary/protocol endpoint

Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus)

Time frame:Baseline, 48 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.