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CompletedPhase 2

NMDA-enhancing Agent for Treatment of Mild Cognitive Impairment and Mild Alzheimer's Disease

Asset

DAOIB

Listed sites

1

Recruiting sites

-

Enrollment

86

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•Alzheimer's disease•MMSE 17-26

Primary endpoint

•Alzheimer's disease assessment scale-cognitive subscale in week 8, 16 and 24

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 ID99-2452A3
NCT IDNCT01600469

Timeline

Milestones

Study start2012-01 (month precision)
Study first posted2012-05-17estimated
Primary completion2013-05actual (month precision)
Study completion2013-05actual (month precision)
Last update posted2013-06-04estimated

Assets

Drug assets

DAOIB

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 mild cognitive impairment or mild Alzheimer's
•MMSE between 17-26
•CDR 0.5 or 1

Exclusion criteria

•Hachinski Ischemic Score > 4
•substance abuse/dependence
•Parkinson disease
•epilepsy
•major depressive disorder
•dementia with psychotic features
•major physical illnesses
•severe visual or hearing impairment

Endpoints (5)

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

Memory
2
Global cognition
1
Function / daily living
1
Other (unclassified)
1

Global cognition

1 endpoint
Secondary/protocol endpoint

Change from baseline in Mini Mental Status Examination at week 8, 16 and 24

Time frame:Week 0, 8, 16, 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Memory

2 endpoints
Secondary/protocol endpoint

Change from baseline in Verbal learning and memory at week 24

Time frame:Week 0, 24

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Digit Span subtest of the Wechsler Memory Scale at week 24

Time frame:Week 0, 24

change from baseline, improvement

Function / daily living

1 endpoint
Secondary/protocol endpoint

Change from baseline in Instrumental Activities of Daily Living 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 Alzheimer's disease assessment scale-cognitive subscale in 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.