NCT03752463

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P50-P75 for phase_2 alzheimer-disease

Timeline
Completed

Started May 2015

Longer than P75 for phase_2 alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2015

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

6.2 years

First QC Date

November 21, 2018

Last Update Submit

August 24, 2021

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

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

    Cognitive assessment

    week 0, 8, 16, 24

Secondary Outcomes (4)

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

    week 8, 16, 24

  • Change from baseline in speed of processing (Category Fluency) at week 24

    week 0, 24

  • Change from baseline in working memory (Wechsler Memory Scale, Spatial Span) at week 24

    week 0, 24

  • Change from baseline in verbal learning and memory tests (Wechsler Memory Scale, Word Listing) at week 24

    week 0, 24

Study Arms (4)

DAOI-A group

EXPERIMENTAL
Drug: DAOI-A group

DAOI-B group

EXPERIMENTAL
Drug: DAOI-B group

DAOI-C group

EXPERIMENTAL
Drug: DAOI-C group

Placebo group

PLACEBO COMPARATOR
Drug: Placebo oral capsule

Interventions

DAOI-A groupDRUG

DAOI with A dose

DAOI-A group
DAOI-B groupDRUG

DAOI with B dose

DAOI-B group
DAOI-C groupDRUG

DAOI with C dose

DAOI-C group
Placebo oral capsuleDRUG

Placebo

Placebo group

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 886, Taiwan

Location

Related Publications (2)

  • 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.

    PMID: 40764372DERIVED

  • 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.

    PMID: 39384087DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2018

First Posted

November 26, 2018

Study Start

May 22, 2015

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

August 26, 2021

Record last verified: 2021-08

Locations

TW(1)