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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Behavioral and Psychological Symptoms in Alzheimer's Disease Behavioral and Psychological Symptoms in Vascular Dementia
Intervention	Drug: DAOIB Drug: Placebo
Phase	Phase 2
Sponsor	Chang Gung Memorial Hospital
Responsible Party	Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier	NCT02103673
First Received	April 1, 2014
Last Updated	April 7, 2014
Last verified	April 2014

Tracking Information[ + expand ][ + ]

First Received Date	April 1, 2014
Last Updated Date	April 7, 2014
Start Date	February 2014
Estimated Primary Completion Date	Not Provided
Current Primary Outcome Measures	Behavioral Pathology in Alzheimer's Disease Rating Scale [Time Frame: weeks 0, 2, 4, 6] [Designated as safety issue: No]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 [Time Frame: weeks 0 and 6] [Designated as safety issue: No]Change from baseline in Alzheimer's Disease Assessment Scale - cognitive subscale at week 6
Current Secondary Outcome Measures	Neuropsychiatirc Inventory [Time Frame: weeks 0 and 6] [Designated as safety issue: No]Change from baseline in Neuropsychiatirc Inventory at week 6 Instrumental Activities of Daily Living [Time Frame: weeks 0 and 6] [Designated as safety issue: No]Changes from baseline in Instrumental Activities of Daily Living at week 6 Zarit Caregiver Burden Interview [Time Frame: weeks 0 and 6] [Designated as safety issue: No]Changes from baseline in Zarit Caregiver Burden Interview at week 6 Geriatric Geriatric Depression Scale [Time Frame: weeks 0, 2, 4, 6] [Designated as safety issue: No]Changes from baseline in Geriatric Depression Scale at weeks 2, 4 and 6 Mini-Mental Status Examination [Time Frame: weeks 0 and 6] [Designated as safety issue: No]Changes from baseline in Mini-Mental Status Examination at week 6

Descriptive Information[ + expand ][ + ]

Brief Title	DAOIB for the Treatment of Cognitive Function and Behavioral and Psychological Symptoms of Dementia
Official Title	Not Provided
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 Provided
Study Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Behavioral and Psychological Symptoms in Alzheimer's Disease Behavioral and Psychological Symptoms in Vascular Dementia
Intervention	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
Study Arm (s)	Experimental: DAOIB Drug: DAOIB 250-1500 mg/day by mouth for 6 weeks Placebo Comparator: Placebo Placebo by mouth per day for 6 weeks

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	90
Estimated Completion Date	Not Provided
Estimated Primary Completion Date	September 2015
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
Gender	Both
Ages	50 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Hsien-Yuan Lane, MD, PhD 886-4-22052121 hylane@gmail.com
Location Countries	Taiwan

Administrative Information[ + expand ][ + ]

NCT Number	NCT02103673
Other Study ID Numbers	102-0035C
Has Data Monitoring Committee	Not Provided
Information Provided By	Chang Gung Memorial Hospital
Study Sponsor	Chang Gung Memorial Hospital
Collaborators	Not Provided
Investigators	Study Chair: Hsien-Yuan Lane, MD, PhD China Medical University Hospital, Taiwan
Verification Date	April 2014

Locations[ + expand ][ + ]

Chang Gung Memorial Hospital	Kaohsiung, Taiwan, 886 Contact: Chieh-Hsin Lin, MD, PhD \| 886-7-73171238753 \| cyndi36@gmail.com Principal Investigator: Chieh-Hsin Lin, MD, PhD Recruiting
China Medical University Hospital	Taichung, Taiwan, 886 Contact: Hsien-Yuan Lane, MD, PhD \| 886-4-220521211074 \| hylane@gmail.com Principal Investigator: Hsien-Yuan Lane, MD, PhD Recruiting