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

• Sponsor: Chang Gung Memorial Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02103673
• Collaborator: (none)
• Enrollment: 90
• Locations: 2
• Arms: 2
• Duration (Months): 45
• Patients Per Site: 45
• Patients Per Site Per Month: 1

Study Details

Study Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Nov 1, 2017
• Actual Study Completion Date: Nov 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Behavioral Pathology in Alzheimer's Disease Rating Scale [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 [weeks 0 and 6]

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

Secondary Outcome Measures

1. Neuropsychiatirc Inventory [weeks 0 and 6]

   Change from baseline in Neuropsychiatirc Inventory at week 6

2. Instrumental Activities of Daily Living [weeks 0 and 6]

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

3. Zarit Caregiver Burden Interview [weeks 0 and 6]

   Changes from baseline in Zarit Caregiver Burden Interview at week 6

4. Geriatric Geriatric Depression Scale [weeks 0, 2, 4, 6]

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

5. Mini-Mental Status Examination [weeks 0 and 6]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Chang Gung Memorial Hospital	Kaohsiung		Taiwan	886
2	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chieh-Hsin Lin, Dr, Chang Gung Memorial Hospital
• ClinicalTrials.gov Identifier: NCT02103673
• Other Study ID Numbers: 102-0035C
• First Posted: Apr 4, 2014
• Last Update Posted: Jan 24, 2018
• Last Verified: Jan 1, 2018

• Additional relevant MeSH terms: Alzheimer Disease; Dementia; Dementia, Vascular

Study Results

No Results Posted as of Jan 24, 2018