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UnknownPhase 2

Efficacy of Chinese Traditional Medicine "Smart Soup" in Cognition and Behavior Regulation in Alzheimer's Disease

Assets

Donepezil / Memantine

Listed sites

1

Recruiting sites

1

Enrollment

180

estimated

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criterion

•Alzheimer's disease

Primary endpoints

•Mini-Mental State Examination (MMSE)•ADAS-Cog•Changes in the degree of dementia

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 IDNCT05538507
Org study IDSmart Soup

Timeline

Milestones

Study start2022-06-01actual
Study first posted2022-09-14actual
Last update posted2022-09-14actual
Primary completion2024-06estimated (month precision)
Study completion2024-06estimated (month precision)

Assets

Drug assets

DonepezilMemantine

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age40 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•NIA-AA 2011 AD probable Alzheimer's disease, mild to moderate, stable use donepezil 10mg/d for 3 months
•NIA-AA 2011 AD probable Alzheimer's disease, severe, stable use donepezil 10mg/d and memantine 20mg/d for 3 months
•NIA-AA 2011 MCI probable criteria
•stable care giver
•Traditional Chinese medicine diagnosis: pixu tanzhuo

Exclusion criteria

•Severe systemic disease (heart, liver ,kidney function failure)
•contradictions of MRI examination

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)
4
Global cognition
2
Behavior / neuropsychiatric
2
Amyloid biomarkers
1
Neuroimaging
1
Caregiver / quality of life
1

Global cognition

2 endpoints
Primary/protocol endpoint

Changes of cognitive screening

Time frame:Through study completion, an average of 1 years

Mini-Mental State Examination (MMSE)

descriptive

Primary/protocol endpoint

Changes of comprehensive cognitive assessment

Time frame:Through study completion, an average of 1 years

ADAS-Cog

descriptive

Behavior / neuropsychiatric

2 endpoints
Primary/protocol endpoint

Changes in behavior

Time frame:Through study completion, an average of 1 years

descriptive

Primary/protocol endpoint

Changes in Psychiatric symptoms

Time frame:Through study completion, an average of 1 years

Neuropsychiatric Inventory (NPI)

descriptive

Amyloid biomarkers

1 endpoint
Primary/protocol endpoint

Tau and Beta-amyloid biomarkers in CSF and plasma

Time frame:Through study completion, an average of 1 years

concentration, descriptive

Neuroimaging

1 endpoint
Primary/protocol endpoint

Magnetic resonance imaging and Electroencephalogram（EEG）

Time frame:Through study completion, an average of 1 years

descriptive

Caregiver / quality of life

1 endpoint
Primary/protocol endpoint

Changes in health status

Time frame:Through study completion, an average of 1 years

categorical status, descriptive

Other (unclassified)

4 endpoints
Primary/protocol endpoint/low confidence

Changes in the degree of dementia

Time frame:Through study completion, an average of 1 years

descriptive

Primary/protocol endpoint/low confidence

Changes of daily living skills

Time frame:Through study completion, an average of 1 years

descriptive

Primary/protocol endpoint/low confidence

Oxidative stress markers in blood

Time frame:Through study completion, an average of 1 years

concentration, descriptive

Primary/protocol endpoint/low confidence

Alterations of neurotransmitters in the blood

Time frame:Through study completion, an average of 1 years

concentration, descriptive

Publications (4)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.