NCT02103673

Brief Summary

The population of dementia is increasing rapidly. Cognitive impairment as well as Behavioral and psychological symptoms of dementia (BPSD) add heavy burdens to caregiver. NMDA activation is critical for learning and memory. Individuals with Alzheimer's disease (AD) have fewer NMDA receptors in the frontal cortex and hippocampus than controls. This study is a randomized, double-blind, placebo-controlled drug trial. All patients will be allocated randomly to two groups: (1) NMDA enhancer: DAOIB (starting dosage: 250-500 mg/day), (2) placebo, for 6 weeks. The investigators hypothesize that DAOIB may yield better efficacy than placebo for cognitive function and clinical symptoms in patients with BPSD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2014

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

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

February 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

January 24, 2018

Status Verified

January 1, 2018

Enrollment Period

3.8 years

First QC Date

April 1, 2014

Last Update Submit

January 23, 2018

Conditions

Behavioral and Psychological Symptoms in Alzheimer's DiseaseBehavioral and Psychological Symptoms in Vascular Dementia

Outcome Measures

Primary Outcomes (2)

  • Behavioral Pathology in Alzheimer's Disease Rating Scale

    Change from baseline in Behavioral Pathology in Alzheimer's Disease Rating Scale at weeks 2, 4 and 6

    weeks 0, 2, 4, 6

  • Alzheimer's Disease Assessment Scale - cognitive subscale

    Change from baseline in Alzheimer's Disease Assessment Scale - cognitive subscale at week 6

    weeks 0 and 6

Secondary Outcomes (5)

  • Neuropsychiatirc Inventory

    weeks 0 and 6

  • Instrumental Activities of Daily Living

    weeks 0 and 6

  • Zarit Caregiver Burden Interview

    weeks 0 and 6

  • Geriatric Geriatric Depression Scale

    weeks 0, 2, 4, 6

  • Mini-Mental Status Examination

    weeks 0 and 6

Study Arms (2)

DAOIB

EXPERIMENTAL

Drug: DAOIB 250-1500 mg/day by mouth for 6 weeks

Drug: DAOIB

Placebo

PLACEBO COMPARATOR

Placebo by mouth per day for 6 weeks

Drug: Placebo

Interventions

DAOIBDRUG

Intervention drug: DAOIB. Dosage: 250-1500 mg/day by mouth. Duration: 6 weeks

DAOIB
PlaceboDRUG

Intervention drug: placebo by mouth. Duration: 6 weeks

Placebo

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of probable Alzheimer's disease or probable vascular dementia
  • For patients with vascular dementia, the post-stroke period must be more than 3 months
  • Mini-Mental State scores between 5-26
  • Clinical Dementia Rating score equal to or greater than 1
  • Behavioral Pathology in Alzheimer's Disease Rating Scale score equal to or greater than 2

You may not qualify if:

  • Current substance abuse or history of substance dependence in the past 6 months
  • Other major psychiatric diagnoses, such as schizophrenia, major depressive disorder, bipolar disorder and mental retardation etc.
  • Serious medical or neurological illness other than Alzheimer's disease/vascular dementia and other secondary dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chang Gung Memorial Hospital

Kaohsiung City, 886, Taiwan

Location

China Medical University Hospital

Taichung, 886, Taiwan

Location

Related Publications (2)

  • Lin CH, Chen PK, Wang SH, Lane HY. Effect of Sodium Benzoate on Cognitive Function Among Patients With Behavioral and Psychological Symptoms of Dementia: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2021 Apr 1;4(4):e216156. doi: 10.1001/jamanetworkopen.2021.6156.

    PMID: 33881530DERIVED

  • Lin CH, Yang HT, Chen PK, Wang SH, Lane HY. Precision Medicine of Sodium Benzoate for the Treatment of Behavioral and Psychological Symptoms of Dementia (BPSD). Neuropsychiatr Dis Treat. 2020 Feb 20;16:509-518. doi: 10.2147/NDT.S234371. eCollection 2020.

    PMID: 32110025DERIVED

MeSH Terms

Conditions

Behavior

Study Officials

  • Hsien-Yuan Lane, MD, PhD

    China Medical University Hospital

    STUDY CHAIR

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
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 1, 2014

First Posted

April 4, 2014

Study Start

February 1, 2014

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

January 24, 2018

Record last verified: 2018-01

Locations

TW(2)