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

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2017-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DAOIB

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

Group Type EXPERIMENTAL

DAOIB

Intervention Type DRUG

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

Placebo

Placebo by mouth per day for 6 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intervention drug: placebo by mouth. Duration: 6 weeks

Interventions

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DAOIB

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

Intervention Type DRUG

Placebo

Intervention drug: placebo by mouth. Duration: 6 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No