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

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ClinicalTrials.gov Identifier: NCT02103673
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Chieh-Hsin Lin, Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Behavioral and Psychological Symptoms in Alzheimer's Disease Behavioral and Psychological Symptoms in Vascular Dementia Drug: DAOIB Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2014
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017


Arm Intervention/treatment
Experimental: DAOIB
Drug: DAOIB 250-1500 mg/day by mouth for 6 weeks
Drug: DAOIB
Intervention drug: DAOIB. Dosage: 250-1500 mg/day by mouth. Duration: 6 weeks

Placebo Comparator: Placebo
Placebo by mouth per day for 6 weeks
Drug: Placebo
Intervention drug: placebo by mouth. Duration: 6 weeks




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   50 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02103673


Locations
Taiwan
Chang Gung Memorial Hospital
Kaohsiung, Taiwan, 886
China Medical University Hospital
Taichung, Taiwan, 886
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Study Chair: Hsien-Yuan Lane, MD, PhD China Medical University Hospital,Taiwan

Responsible Party: Chieh-Hsin Lin, Dr, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02103673     History of Changes
Other Study ID Numbers: 102-0035C
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Dementia, Vascular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases