DAOIB for the Treatment of Cognitive Function and Behavioral and Psychological Symptoms of Dementia

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.

Study Overview

• Status: Completed
• Conditions: Behavioral and Psychological Symptoms in Alzheimer's Disease; Behavioral and Psychological Symptoms in Vascular Dementia
• Intervention / Treatment: Drug: DAOIB; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 886
    • Chang Gung memorial hospital
  • Taichung, Taiwan, 886
    • China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DAOIB; Drug: DAOIB 250-1500 mg/day by mouth for 6 weeks	Drug: DAOIB; Intervention drug: DAOIB. Dosage: 250-1500 mg/day by mouth. Duration: 6 weeks
Placebo Comparator: Placebo; Placebo by mouth per day for 6 weeks	Drug: Placebo; Intervention drug: placebo by mouth. Duration: 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropsychiatirc Inventory	Change from baseline in Neuropsychiatirc Inventory at week 6	weeks 0 and 6
Instrumental Activities of Daily Living	Changes from baseline in Instrumental Activities of Daily Living at week 6	weeks 0 and 6
Zarit Caregiver Burden Interview	Changes from baseline in Zarit Caregiver Burden Interview at week 6	weeks 0 and 6
Geriatric Geriatric Depression Scale	Changes from baseline in Geriatric Depression Scale at weeks 2, 4 and 6	weeks 0, 2, 4, 6
Mini-Mental Status Examination	Changes from baseline in Mini-Mental Status Examination at week 6	weeks 0 and 6

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Study Chair: Hsien-Yuan Lane, MD, PhD, China Medical University Hospital,Taiwan

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: April 1, 2014
• First Submitted That Met QC Criteria: April 3, 2014
• First Posted (Estimate): April 4, 2014

Study Record Updates

• Last Update Posted (Actual): January 24, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Intracranial Arterial Diseases; Intracranial Arteriosclerosis; Leukoencephalopathies; Dementia; Alzheimer Disease; Dementia, Vascular
• Other Study ID Numbers: 102-0035C