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CompletedPhase 2

Multidisciplinary Study of Novel NMDA Modulation for Neurodegenerative Disorder

Lead sponsor

China Medical University Hospital

Asset

DAAOI-P

Listed sites

Recruiting sites

Enrollment

actual

Study population

Lewy body dementia

Key I/E criteria

•Parkinson's disease dementia•MMSE 10-26

Primary endpoint

•Improvement of gait and neuropsychiatric symptoms

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 IDCMUH105-REC1-023

NCT IDNCT04470037

Timeline

Milestones

Study start2016-04actual (month precision)

Study first posted2020-07-14actual

Primary completion2024-12actual (month precision)

Study completion2025-09actual (month precision)

Last update posted2025-11-19actual

Assets

Drug assets

DAAOI-P

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age50 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•PD-D will be diagnosed according to the criteria proposed by Movement Disorder Society task force statement. (Emre et al. 2007) . The following wordings are modified from the task force statement. I. Core features

1. Diagnosis of PD according to Queen Square Brain Bank criteria

2. A dementia syndrome with insidious onset and slow progression, developing within the context of established PD and diagnosed by history, clinical, and mental examination, defined as:

-Impairment in more than one cognitive domain

-Representing a decline from premorbid level

-Deficits severe enough to impair daily life, independent of the impairment ascribable to motor or autonomic symptoms

-MMSE score between 10-26.

II. Associated clinical features

1. Cognitive features: Impaired attention, executive functions, visuo-spatial functions or memory. Core functions of language are largely preserved.

2. Behavioral features:

-Apathy

-Changes in personality and mood

-Hallucination• Delusions

-Excessive daytime sleepiness

III. Features which do not exclude PD-D, but make the diagnosis uncertain

•Co-existence of any other abnormality which may by itself cause cognitive impairment, but judged not to be the cause of dementia.

•Time interval between the development of motor and cognitive symptoms is uncertain

IV. Features suggesting other conditions or diseases as cause of mental impairment, which, when present make it impossible to reliably diagnose PD-D

•Cognitive and behavioral symptoms appearing solely in the context of other conditions such as:

1. Acute confusion due to systemic illnesses or drug intoxication.

2. Major depression

•Features compatible with "Probable Vascular dementia" criteria according to NINDS-AIREN Criteria for the diagnosis of probable and possible PD-D [Probable PD-D] Both core features must be present. In associated clinical features, typical profile of cognitive deficits should be present in at least 2 of the 4 core cognitive domains. The presence of at least one behavioral symptom supports the diagnosis of probable PD-D. None of group III and IV features is present. [Possible PD-D] Both core features must be present. In associated clinical features, the cognitive impairment is atypical in one or more domains. The behavioral symptoms are not necessary to be present. One or more of the group III features may be present. No group IV feature is allowed to be present

Exclusion criteria

1. Patients with uncontrollable malignancy, severe heart failure, uremia under hemodialysis, or decompensated liver cirrhosis.

2. Patients taking anticholinergics within 30 days of recruitment.

Endpoints (13)

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

Memory

Behavior / neuropsychiatric

Other clinical outcomes

Global cognition

2 endpoints

Secondary/protocol endpoint

Cognitive function

Time frame:week 0, 8, 16, 24

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Severity of dementia

Time frame:week 0, 8, 16, 24

change from baseline, improvement

Memory

2 endpoints

Secondary/protocol endpoint

Neuroimaging examinations

Time frame:week 0, 24

descriptive

Secondary/protocol endpoint

Emotion recognition and imitation

Time frame:week 0, 8, 16, 24

descriptive

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Neuropsychiatric symptoms

Time frame:week 0, 8, 16, 24

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Fall assessment

Time frame:week 0, 8, 16, 24

descriptive

Other (unclassified)

7 endpoints

Primary/protocol endpoint/low confidence

The improvement of gait and neuropsychiatric symptoms

Time frame:week 0, 8, 16, 24

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Gait function

Time frame:week 0, 8, 16, 24

descriptive

Secondary/protocol endpoint/low confidence

The improvement of Parkinson's disease

Time frame:week 0, 8, 16, 24

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Behavioral Pathology of dementia

Time frame:week 0, 8, 16, 24

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Face perception

Time frame:week 0, 8, 16, 24

descriptive

Secondary/protocol endpoint/low confidence

Transcranial magnetic stimulation

Time frame:week 0, 8, 16, 24

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Electroencephalography

Time frame:week 0, 8, 16, 24

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.