NMDA Enhancer for the Treatment of Mild Alzheimer's Disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03752463

Enrollment

154

Registered

2018-11-26

Start date

2015-05-22

Completion date

2021-07-31

Last updated

2021-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Brief summary

NMDA neurotransmission plays an important role in learning and memory. NMDA receptors (NMDAR) were found to decrease in the frontal lobe and hippocampus of Alzheimer's disease (AD). This study is a randomized, double-blind, placebo controlled drug trial for testing the efficacy of NMDAR-enhancer. All subjects will be allocated randomly to 4 groups: (1) DAOI-A group; (2) DAOI-B group; (3) DAOI-C group; (4) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOI may yield better efficacy than placebo for cognitive function in patients with AD.

Interventions

DRUGDAOI-A group

DAOI with A dose

DRUGDAOI-B group

DAOI with B dose

DRUGDAOI-C group

DAOI with C dose

DRUGPlacebo oral capsule

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 100 Years

Healthy volunteers

Inclusion criteria

* Clinical diagnosis of Alzheimer's disease * MMSE between 10-26 * CDR 1

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

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24	week 0, 8, 16, 24	Cognitive assessment

Secondary

Measure	Time frame	Description
Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input at week 8, 16 and 24	week 8, 16, 24	Global assessment
Change from baseline in speed of processing (Category Fluency) at week 24	week 0, 24	Cognitive assessment
Change from baseline in working memory (Wechsler Memory Scale, Spatial Span) at week 24	week 0, 24	Cognitive assessment
Change from baseline in verbal learning and memory tests (Wechsler Memory Scale, Word Listing) at week 24	week 0, 24	Cognitive assessment

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026