NMDA-enhancing Agent for Treatment of Mild Cognitive Impairment and Mild Alzheimer's Disease
1 other identifier
interventional
86
1 country
1
Brief Summary
NMDA activation plays an important role in learning and memory. NMDA receptors were found to decrease in the frontal lobe and hippocampus of Alzheimer's disease and mild cognitive function impairment. This study is a randomized, double-blind, placebo-controlled drug trial. All patients will be allocated randomly to 2 groups: (1) NMDA enhancer: DAOI-B group (starting dose: 250-500 mg/d); (2) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOI-B may yield better efficacy than placebo for cognitive function in patients with mild cognitive impairment or mild Alzheimer's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2012
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 14, 2012
CompletedFirst Posted
Study publicly available on registry
May 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedJune 4, 2013
April 1, 2011
1.3 years
May 14, 2012
June 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in Alzheimer's disease assessment scale-cognitive subscale in week 8, 16 and 24
Week 0, 8, 16, 24
Secondary Outcomes (4)
Change from baseline in Mini Mental Status Examination at week 8, 16 and 24
Week 0, 8, 16, 24
Change from baseline in Instrumental Activities of Daily Living at week 8, 16 and 24
Week 0, 8, 16, 24
Change from baseline in Verbal learning and memory at week 24
Week 0, 24
Change from baseline in Digit Span subtest of the Wechsler Memory Scale at week 24
Week 0, 24
Study Arms (2)
DAOI-B
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of mild cognitive impairment or mild Alzheimer's
- MMSE between 17-26
- CDR 0.5 or 1
You may not qualify if:
- Hachinski Ischemic Score \> 4
- substance abuse/dependence
- Parkinson disease
- epilepsy
- major depressive disorder
- dementia with psychotic features
- major physical illnesses
- severe visual or hearing impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Taiwan, 886, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hsien-yuan Lane, MD, PhD
Departments of Psychiatry, China Medical University Hospital, Taichung, Taiwan
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2012
First Posted
May 17, 2012
Study Start
January 1, 2012
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
June 4, 2013
Record last verified: 2011-04