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NCT Number: NCT02103673

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

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.

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Key information

Conditions

Behavioral and Psychological Symptoms in Alzheimer's Disease Behavior Behavioral and Psychological Symptoms in Vascular Dementia

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chang Gung Memorial Hospital, Kaohsiung City, Taiwan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DAOIB

Drug

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

Placebo

Drug

Intervention drug: placebo by mouth. Duration: 6 weeks

Primary outcomes

  1. Behavioral Pathology in Alzheimer's Disease Rating Scale

    Time frame: weeks 0, 2, 4, 6

    Change from baseline in Behavioral Pathology in Alzheimer's Disease Rating Scale at weeks 2, 4 and 6

  2. Alzheimer's Disease Assessment Scale - cognitive subscale

    Time frame: weeks 0 and 6

    Change from baseline in Alzheimer's Disease Assessment Scale - cognitive subscale at week 6

Secondary outcomes

  1. Neuropsychiatirc Inventory

    Time frame: weeks 0 and 6

    Change from baseline in Neuropsychiatirc Inventory at week 6

  2. Instrumental Activities of Daily Living

    Time frame: weeks 0 and 6

    Changes from baseline in Instrumental Activities of Daily Living at week 6

  3. Zarit Caregiver Burden Interview

    Time frame: weeks 0 and 6

    Changes from baseline in Zarit Caregiver Burden Interview at week 6

  4. Geriatric Geriatric Depression Scale

    Time frame: weeks 0, 2, 4, 6

    Changes from baseline in Geriatric Depression Scale at weeks 2, 4 and 6

  5. Mini-Mental Status Examination

    Time frame: weeks 0 and 6

    Changes from baseline in Mini-Mental Status Examination at week 6

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 4, 2014
Registry last updated
Jan 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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