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

NCT02103673 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2018-01-24

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

DAOIB

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

DRUG

Placebo

Intervention drug: placebo by mouth. Duration: 6 weeks

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Hsien-Yuan Lane, MD, PhD · China Medical University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • Taiwan

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02103673 on ClinicalTrials.gov