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

Behavioral and Psychological Symptoms in Alzheimer's Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02103673
• Other study ID #: 102-0035C
• Status: Completed
• Phase: Phase 2
• First received: April 1, 2014
• Last updated: January 23, 2018
• Start date: February 2014
• Est. completion date: November 2017

Study information

• Verified date: January 2018
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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