← Trials/Trial dossier/NCT03151382

UnknownPhase 4

A Based on PEEG and PET Study of Anxiolytic Treatment to Improve Cognitive Function in Patients With Alzheimer Disease

Lead sponsor

Zhejiang Provincial People's Hospital

Assets

Donepezil / Tandospirone Citrate

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-24

Primary endpoints

•ADAS-Cog•Neuropsychiatric Inventory (NPI)

Identifiers

Registered as

NCT IDNCT03151382

Org study IDSED-AD

Secondary IDSED-AD-2016-001Sumitomo Pharma （Suzhou） Co..Ltd

Timeline

Milestones

Study first posted2017-05-12actual

Last update posted2017-05-12actual

Study start2017-05-20estimated

Primary completion2017-12-31estimated

Study completion2018-06-30estimated

Assets

Drug assets

Donepezil Tandospirone Citrate

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•55-80 years old (including 55 and 80), male or female, sufficient vision, hearing and general health to complete the follow-up and assessment;

•Patients who were diagnosed with AD according to the DSM-IV;

•MMSE score > 10 and ≤ 24;

•HAMA score > 8;

•HAMD score ≤ 7;

•Brain CT or MRI supports the diagnosis of AD;

•Provide written informed consent by the patient himself and his family member or guardian

Exclusion criteria

•Dementia from any other cause;

•Brain MRI showed that the diameter of hyperintense lesions in T2-FLAIR sequences were larger than 5mm;

•Patients with significant cardiac, pulmonary, hepatic, renal, or hematologic disease;

•Any primary neurologic or psychiatric disease other than AD;

•Mental disorders due to substance abuse;

•Participation in other clinical studies within the last 30 days;

•History of alcohol or substance abuse or dependence within the past year;

•Pregnant or breastfeeding, or of child-bearing potential during the study.

Endpoints (7)

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

Executive function / language

Behavior / neuropsychiatric

Global cognition

2 endpoints

Primary/protocol endpoint

Change of ADAS-cog total score

Time frame:week 12

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

MMSE score

Time frame:week 12

Mini-Mental State Examination (MMSE)

descriptive

Executive function / language

1 endpoint

Secondary/protocol endpoint

FAB score

Time frame:week 12

descriptive

Behavior / neuropsychiatric

1 endpoint

Primary/protocol endpoint

NPI scale total score

Time frame:week 12

Neuropsychiatric Inventory (NPI)

descriptive

Other (unclassified)

3 endpoints

Secondary/protocol endpoint/low confidence

HAMA total score

Time frame:week 12

descriptive

Secondary/protocol endpoint/low confidence

relative power

Time frame:week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

the image of PET

Time frame:week 12

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.