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

Phase 2

Completed

• Conditions: Behavioral and Psychological Symptoms in Alzheimer's Disease; Behavioral and Psychological Symptoms in Vascular Dementia
• Interventions: Drug: DAOIB; Drug: Placebo

• Registration Number: NCT02103673
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-04-01
• Study First Submitted QC: 2014-04-03
• Study First Posted: 2014-04-04
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DAOIB	DAOIB	Drug: DAOIB 250-1500 mg/day by mouth for 6 weeks
Placebo	Placebo	Placebo by mouth per day for 6 weeks

Primary Outcome Measures

Name	Time	Method
Alzheimer's Disease Assessment Scale - cognitive subscale	weeks 0 and 6	Change from baseline in Alzheimer's Disease Assessment Scale - cognitive subscale at week 6
Behavioral Pathology in Alzheimer's Disease Rating Scale	weeks 0, 2, 4, 6	Change from baseline in Behavioral Pathology in Alzheimer's Disease Rating Scale at weeks 2, 4 and 6

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

China Medical University Hospital; 🇨🇳 Taichung, Taiwan