Back to resultsDAOIB for the Treatment of Cognitive Function and Behavioral and Psychological Symptoms of Dementia
Primary Purpose
Behavioral and Psychological Symptoms in Alzheimer's Disease, Behavioral and Psychological Symptoms in Vascular Dementia
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
DAOIB
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Behavioral and Psychological Symptoms in Alzheimer's Disease
Eligibility Criteria
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
Sites / Locations
- Chang Gung Memorial Hospital
- China Medical University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DAOIB
Placebo
Arm Description
Drug: DAOIB 250-1500 mg/day by mouth for 6 weeks
Placebo by mouth per day for 6 weeks
Outcomes
Primary Outcome Measures
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
Alzheimer's Disease Assessment Scale - cognitive subscale
Change from baseline in Alzheimer's Disease Assessment Scale - cognitive subscale at week 6
Secondary Outcome Measures
Neuropsychiatirc Inventory
Change from baseline in Neuropsychiatirc Inventory at week 6
Instrumental Activities of Daily Living
Changes from baseline in Instrumental Activities of Daily Living at week 6
Zarit Caregiver Burden Interview
Changes from baseline in Zarit Caregiver Burden Interview at week 6
Geriatric Geriatric Depression Scale
Changes from baseline in Geriatric Depression Scale at weeks 2, 4 and 6
Mini-Mental Status Examination
Changes from baseline in Mini-Mental Status Examination at week 6
Full Information
NCT ID
NCT02103673
First Posted
April 1, 2014
Last Updated
January 23, 2018
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02103673
Brief Title
DAOIB for the Treatment of Cognitive Function and Behavioral and Psychological Symptoms of Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavioral and Psychological Symptoms in Alzheimer's Disease, Behavioral and Psychological Symptoms in Vascular Dementia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DAOIB
Arm Type
Experimental
Arm Description
Drug: DAOIB 250-1500 mg/day by mouth for 6 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo by mouth per day for 6 weeks
Intervention Type
Drug
Intervention Name(s)
DAOIB
Intervention Description
Intervention drug: DAOIB. Dosage: 250-1500 mg/day by mouth. Duration: 6 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intervention drug: placebo by mouth. Duration: 6 weeks
Primary Outcome Measure Information:
Title
Behavioral Pathology in Alzheimer's Disease Rating Scale
Description
Change from baseline in Behavioral Pathology in Alzheimer's Disease Rating Scale at weeks 2, 4 and 6
Time Frame
weeks 0, 2, 4, 6
Title
Alzheimer's Disease Assessment Scale - cognitive subscale
Description
Change from baseline in Alzheimer's Disease Assessment Scale - cognitive subscale at week 6
Time Frame
weeks 0 and 6
Secondary Outcome Measure Information:
Title
Neuropsychiatirc Inventory
Description
Change from baseline in Neuropsychiatirc Inventory at week 6
Time Frame
weeks 0 and 6
Title
Instrumental Activities of Daily Living
Description
Changes from baseline in Instrumental Activities of Daily Living at week 6
Time Frame
weeks 0 and 6
Title
Zarit Caregiver Burden Interview
Description
Changes from baseline in Zarit Caregiver Burden Interview at week 6
Time Frame
weeks 0 and 6
Title
Geriatric Geriatric Depression Scale
Description
Changes from baseline in Geriatric Depression Scale at weeks 2, 4 and 6
Time Frame
weeks 0, 2, 4, 6
Title
Mini-Mental Status Examination
Description
Changes from baseline in Mini-Mental Status Examination at week 6
Time Frame
weeks 0 and 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsien-Yuan Lane, MD, PhD
Organizational Affiliation
China Medical University Hospital,Taiwan
Official's Role
Study Chair
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
886
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
886
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
33881530
Citation
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.
Results Reference
derived
PubMed Identifier
32110025
Citation
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.
Results Reference
derived
Learn more about this trial
DAOIB for the Treatment of Cognitive Function and Behavioral and Psychological Symptoms of Dementia
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