NMDA Enhancer for the Treatment of Mild Alzheimer's Disease

NCT ID: NCT03752463

Last Updated: 2021-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-22

Study Completion Date

2021-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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DAOI-A group

Group Type EXPERIMENTAL

DAOI-A group

Intervention Type DRUG

DAOI with A dose

DAOI-B group

Group Type EXPERIMENTAL

DAOI-B group

Intervention Type DRUG

DAOI with B dose

DAOI-C group

Group Type EXPERIMENTAL

DAOI-C group

Intervention Type DRUG

DAOI with C dose

Placebo group

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

Placebo

Interventions

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DAOI-A group

DAOI with A dose

Intervention Type DRUG

DAOI-B group

DAOI with B dose

Intervention Type DRUG

DAOI-C group

DAOI with C dose

Intervention Type DRUG

Placebo oral capsule

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Science and Technology, Taiwan

OTHER_GOV

Sponsor Role collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

References

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Lin CH, Lane HY. Sodium benzoate treatment decreased amyloid beta peptides and improved cognitive function among patients with Alzheimer's disease: secondary analysis of a randomized clinical trial. Transl Psychiatry. 2025 Aug 5;15(1):264. doi: 10.1038/s41398-025-03492-3.

Reference Type DERIVED
PMID: 40764372 (View on PubMed)

Lane HY, Wang SH, Lin CH. Sex- and dose-dependent catalase increase and its clinical impact in a benzoate dose-finding, randomized, double-blind, placebo-controlled trial for Alzheimer's disease. Pharmacol Biochem Behav. 2024 Dec;245:173885. doi: 10.1016/j.pbb.2024.173885. Epub 2024 Oct 9.

Reference Type DERIVED
PMID: 39384087 (View on PubMed)

Other Identifiers

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105-3412C

Identifier Type: -

Identifier Source: org_study_id

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