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CompletedPhase 2

Preliminary Efficacy and Safety Study of ST101 Plus Aricept in Alzheimer's Disease

A Double-Blind Placebo-Controlled Preliminary Study of the Efficacy, Safety and Tolerability of ST101 Tablets in the Treatment of Alzheimer's Disease in Subjects Concurrently Receiving Donepezil (Aricept®)

Asset

ST101

Listed sites

30

Recruiting sites

-

Enrollment

210

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•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 IDNCT00842816
Org study IDST101-A001-202

Timeline

Milestones

Study start2009-02 (month precision)
Study first posted2009-02-12estimated
Primary completion2011-05actual (month precision)
Study completion2011-05actual (month precision)
Last update posted2012-06-07estimated

Assets

Drug assets

ST101

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Subjects must be receiving concurrent treatment with 10 mg/day of Aricept (donepezil). The dose shall have been stable for three (3) months (90 days) prior to Screening.
•Diagnostic evidence of Moderate to Moderately Severe Probable Alzheimer's disease
•CT or MRI results within the past 18 months that rule out dementia due to non-Alzheimer's etiology.
•A reliable and capable caregiver

Exclusion criteria

•Subjects who reside in a skilled nursing facility.
•Subjects with B12 or folate deficiency.
•Subjects with chronic hepatic disease.
•Subjects with a recent history of hematologic/oncologic disorders.
•Subjects who have experienced a myocardial infarction with the past year.

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
1
Function / daily living
1
Behavior / neuropsychiatric
1
Other clinical outcomes
1

Global cognition

1 endpoint
Primary/protocol endpoint

Alzheimer's Disease Assessment Scale, cognitive subscale (ADAS-cog)

Time frame:Baseline, 4 weeks, 8 weeks, 12 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, 4 weeks, 8 weeks, 12 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

Neuropsychiatric Inventory (NPI)

Time frame:Baseline, 4 weeks, 8 weeks, 12 weeks

Neuropsychiatric Inventory (NPI)

descriptive

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Alzheimer's Disease Cooperative Study- Clinical Global Impression (ADCS-CGI)

Time frame:Baseline (severity); 4 weeks, 8 weeks, 12 weeks (change)

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.