NMDA-enhancing Agent for Treatment of Mild Cognitive Impairment and Mild Alzheimer's Disease

Chang Gung Memorial Hospital1 site in 1 country86 target enrollmentJanuary 2012

ConditionsAlzheimer's Disease Mild Cognitive Impairment

InterventionsPlacebo DAOI-B

DrugsDAOI-B

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Alzheimer's Disease
Sponsor: Chang Gung Memorial Hospital
Enrollment: 86
Locations: 1
Primary Endpoint: Change from baseline in Alzheimer's disease assessment scale-cognitive subscale in week 8, 16 and 24
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

May 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chang Gung Memorial Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Clinical diagnosis of mild cognitive impairment or mild Alzheimer's
•MMSE between 17-26
•CDR 0.5 or 1

Exclusion Criteria

•Hachinski Ischemic Score \> 4
•substance abuse/dependence
•Parkinson disease
•major depressive disorder
•dementia with psychotic features
•major physical illnesses
•severe visual or hearing impairment

Arms & Interventions

Placebo

Intervention: Placebo

DAOI-B

Intervention: DAOI-B

Outcomes

Primary Outcomes

Change from baseline in Alzheimer's disease assessment scale-cognitive subscale in week 8, 16 and 24

Time Frame: Week 0, 8, 16, 24

Secondary Outcomes

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)