Clinical trial NCT02103673: DAOIB for the Treatment of Cognitive Function and Behavioral and Psychological Symptoms of Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Behavioral and Psychological Symptoms in Alzheimer's Disease
Behavioral and Psychological Symptoms in Vascular Dementia
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2014-04-04
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Behavioral Pathology in Alzheimer's Disease Rating Scale
timeFrame: weeks 0, 2, 4, 6
measure: Alzheimer's Disease Assessment Scale - cognitive subscale
timeFrame: weeks 0 and 6
Secondary outcomes:
measure: Neuropsychiatirc Inventory
timeFrame: weeks 0 and 6
measure: Instrumental Activities of Daily Living
timeFrame: weeks 0 and 6
measure: Zarit Caregiver Burden Interview
timeFrame: weeks 0 and 6
measure: Geriatric Geriatric Depression Scale
timeFrame: weeks 0, 2, 4, 6
measure: Mini-Mental Status Examination
timeFrame: weeks 0 and 6
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital,Taiwan
name: Hsien-Yuan Lane, MD, PhD
role: STUDY_CHAIR
References:
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.
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.