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

Chang Gung Medical Foundation

Status and phase: Completed; Phase 2

Conditions: Behavioral and Psychological Symptoms in Vascular Dementia; Behavioral and Psychological Symptoms in Alzheimer's Disease

Treatments: Drug: Placebo; Drug: DAOIB

Study type: Interventional

Funder types: Other

Identifiers

NCT02103673

102-0035C

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 50 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

DAOIB

Experimental group

Description:

Drug: DAOIB 250-1500 mg/day by mouth for 6 weeks

Treatment:

Drug: DAOIB

Placebo

Placebo Comparator group

Description:

Placebo by mouth per day for 6 weeks

Treatment:

Drug: Placebo