NCT04736355

Brief Summary

NMDA neurotransmission plays an important role in learning and memory. NMDA receptor-enhancing agent improved the cognitive function of patients with early-phase Alzheimer's disease. This study is a randomized, double-blind, placebo-controlled drug trial. All subjects will be allocated randomly to 2 groups: (1) DAOIB group; (2) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOIB may yield better efficacy than placebo for cognitive function in patients with mild cognitive impairment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2020

Typical duration for phase_2

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

January 1, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

August 21, 2024

Status Verified

February 1, 2024

Enrollment Period

4.5 years

First QC Date

January 31, 2021

Last Update Submit

August 19, 2024

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

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

    Alzheimer's disease assessment scale-cognitive subscale consists of 11 tasks. Its scores range from 0 (best) to 70 (worst).

    week 0, 8, 16, 24

Secondary Outcomes (4)

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

    week 8, 16, 24

  • Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 8, 16 and 24

    week 0, 8, 16, 24

  • Change from baseline in Medical Outcomes Study Short-Form-36 (SF-36) score at week 8, 16 and 24

    week 0, 8, 16, 24

  • Change from baseline in the composite score of a battery of additional cognitive tests at week 8, 16 and 24

    week 0, 24

Study Arms (2)

DAOIB

EXPERIMENTAL

oral, for 24 weeks

Drug: DAOIB

Placebo

PLACEBO COMPARATOR

oral, for 24 weeks

Drug: Placebo

Interventions

DAOIBDRUG

oral, for 24 weeks

DAOIB
PlaceboDRUG

oral, for 24 weeks

Placebo

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of mild cognitive impairment
  • MMSE between 17-26
  • CDR 0.5

You may not qualify if:

  • Hachinski Ischemic Score \> 4
  • Substance abuse/dependence
  • Parkinson disease, epilepsy, dementia with psychotic features
  • Major psychiatric disorders
  • Major physical illnesses
  • Severe visual or hearing impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Kaohsiung City, 886, Taiwan

Location

Related Publications (1)

  • Lin CH, Wang SH, Lane HY. Sodium benzoate, a D-amino acid oxidase inhibitor, improved short-term memory in patients with mild cognitive impairment in a randomized, double-blind, placebo-controlled clinical trial. Psychiatry Clin Neurosci. 2025 Aug;79(8):466-472. doi: 10.1111/pcn.13841. Epub 2025 May 23.

    PMID: 40405827DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

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

Study Record Dates

First Submitted

January 31, 2021

First Posted

February 3, 2021

Study Start

January 1, 2020

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

August 21, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)