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

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2016 by Chieh-Hsin Lin, Chang Gung Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Chieh-Hsin Lin, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT02103673
First received: April 1, 2014
Last updated: August 2, 2016
Last verified: August 2016
  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 Intervention 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
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Chieh-Hsin Lin, Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • 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

  • 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:
  • Neuropsychiatirc Inventory [ Time Frame: weeks 0 and 6 ]
    Change from baseline in Neuropsychiatirc Inventory at week 6

  • Instrumental Activities of Daily Living [ Time Frame: weeks 0 and 6 ]
    Changes from baseline in Instrumental Activities of Daily Living at week 6

  • Zarit Caregiver Burden Interview [ Time Frame: weeks 0 and 6 ]
    Changes from baseline in Zarit Caregiver Burden Interview at week 6

  • Geriatric Geriatric Depression Scale [ Time Frame: weeks 0, 2, 4, 6 ]
    Changes from baseline in Geriatric Depression Scale at weeks 2, 4 and 6

  • Mini-Mental Status Examination [ Time Frame: weeks 0 and 6 ]
    Changes from baseline in Mini-Mental Status Examination at week 6


Estimated Enrollment: 90
Study Start Date: February 2014
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 100 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02103673

Contacts
Contact: Hsien-Yuan Lane, MD, PhD 886-4-22052121 ext 1074 hylane@gmail.com

Locations
Taiwan
Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan, 886
Contact: Chieh-Hsin Lin, MD, PhD    886-7-7317123 ext 8753    cyndi36@gmail.com   
Principal Investigator: Chieh-Hsin Lin, MD, PhD         
China Medical University Hospital Recruiting
Taichung, Taiwan, 886
Contact: Hsien-Yuan Lane, MD, PhD    886-4-22052121 ext 1074    hylane@gmail.com   
Principal Investigator: Hsien-Yuan Lane, MD, PhD         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Study Chair: Hsien-Yuan Lane, MD, PhD China Medical University Hospital, Taiwan
  More Information

Responsible Party: Chieh-Hsin Lin, Dr, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02103673     History of Changes
Other Study ID Numbers: 102-0035C
Study First Received: April 1, 2014
Last Updated: August 2, 2016

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

ClinicalTrials.gov processed this record on August 23, 2017