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RecruitingPhase 2

Novel Augmentation of DAOIB and Antioxidant for Early Dementia

Asset

DAOIB plus AO

Listed sites

1

Recruiting sites

1

Enrollment

80

estimated

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•Alzheimer's disease•MMSE 10-26

Primary endpoint

•The 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 ID202200458A3C502
NCT IDNCT06467539

Timeline

Milestones

Study start2024-06-19actual
Study first posted2024-06-21actual
Last update posted2026-03-19actual
Primary completion2027-05estimated (month precision)
Study completion2027-05estimated (month precision)

Assets

Drug assets

DAOIB plus AO

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Clinical diagnosis of Alzheimer's disease or mild cognitive impairment
•MMSE between 10-26
•CDR 1 or 0.5

Exclusion criteria

•Hachinski Ischemic Score > 4
•Substance abuse/dependence
•Parkinson disease, epilepsy, dementia with psychotic features
•Major depressive disorder
•Major physical illnesses
•Severe visual or hearing impairment

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

Global cognition
2
Caregiver / quality of life
2
Memory
1
Function / daily living
1
Other (unclassified)
1

Global cognition

2 endpoints
Secondary/protocol endpoint

Change from baseline in Mini-Mental Status examination score at week 8, 16 and 24

Time frame:week 0, 8, 16, 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score at week 8, 16 and 24

Time frame:week 0, 8, 16, 24

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Memory

1 endpoint
Secondary/protocol endpoint

Change from baseline in the composite score of a battery of additional cognitive tests at week 8, 16 and 24

Time frame:week 0, 24

change from baseline, improvement

Function / daily living

1 endpoint
Secondary/protocol endpoint

Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 8, 16 and 24

Time frame:week 0, 8, 16, 24

change from baseline, improvement

Caregiver / quality of life

2 endpoints
Secondary/protocol endpoint

Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24

Time frame:week 8, 16, 24

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Medical Outcomes Study Short-Form-36 (SF-36) score at week 8, 16 and 24

Time frame:week 0, 8, 16, 24

change from baseline, improvement

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24

Time frame:week 0, 8, 16, 24

change from baseline, improvement

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.