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CompletedPhase 2

DAOIB for the Treatment of Cognitive Function and Behavioral and Psychological Symptoms of Dementia

Asset

DAOIB

Listed sites

2

Recruiting sites

-

Enrollment

90

actual

Study population

Alzheimer’s disease, Vascular cognitive impairment / dementia

Key I/E criterion

•Multiple dementia etiologies

Primary endpoints

•Behavioral Pathology in Alzheimer's Disease Rating Scale•Alzheimer's Disease Assessment Scale - cognitive subscale

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 ID102-0035C
NCT IDNCT02103673

Timeline

Milestones

Study start2014-02 (month precision)
Study first posted2014-04-04estimated
Primary completion2017-11actual (month precision)
Study completion2017-11actual (month precision)
Last update posted2018-01-24actual

Assets

Drug assets

DAOIB

Study populations

Who this study enrolls

Alzheimer’s diseaseVascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age50 Years
Maximum age100 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Clinical diagnosis of probable Alzheimer's disease or probable vascular dementia
•For patients with vascular dementia, the post-stroke period must be more than 3 months
•Mini-Mental State scores between 5-26
•Clinical Dementia Rating score equal to or greater than 1
•Behavioral Pathology in Alzheimer's Disease Rating Scale score equal to or greater than 2

Exclusion criteria

•Current substance abuse or history of substance dependence in the past 6 months
•Other major psychiatric diagnoses, such as schizophrenia, major depressive disorder, bipolar disorder and mental retardation etc.
•Serious medical or neurological illness other than Alzheimer's disease/vascular dementia and other secondary dementia

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)
3
Global cognition
1
Function / daily living
1
Behavior / neuropsychiatric
1
Caregiver / quality of life
1

Global cognition

1 endpoint
Secondary/protocol endpoint

Mini-Mental Status Examination

Time frame:weeks 0 and 6

Mini-Mental State Examination (MMSE)

categorical status, descriptive

Function / daily living

1 endpoint
Secondary/protocol endpoint

Instrumental Activities of Daily Living

Time frame:weeks 0 and 6

descriptive

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

Geriatric Geriatric Depression Scale

Time frame:weeks 0, 2, 4, 6

descriptive

Caregiver / quality of life

1 endpoint
Secondary/protocol endpoint

Zarit Caregiver Burden Interview

Time frame:weeks 0 and 6

descriptive

Other (unclassified)

3 endpoints
Primary/protocol endpoint/low confidence

Behavioral Pathology in Alzheimer's Disease Rating Scale

Time frame:weeks 0, 2, 4, 6

change from baseline, improvement

Primary/protocol endpoint/low confidence

Alzheimer's Disease Assessment Scale - cognitive subscale

Time frame:weeks 0 and 6

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Neuropsychiatirc Inventory

Time frame:weeks 0 and 6

change from baseline, improvement

Publications (2)

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.