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

Phase 2

Completed

• Conditions: Alzheimer's Disease; Mild Cognitive Impairment
• Interventions: Drug: DAOI-B; Other: Placebo

• Registration Number: NCT01600469
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-04
• Study Start: 2012-01
• Study First Submitted: 2012-05-14
• Study First Submitted QC: 2012-05-15
• Study First Posted: 2012-05-17
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2013-06-03
• Last Update Posted: 2013-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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
• epilepsy
• major depressive disorder
• dementia with psychotic features
• major physical illnesses
• severe visual or hearing impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DAOI-B	DAOI-B	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in Alzheimer's disease assessment scale-cognitive subscale in week 8, 16 and 24	Week 0, 8, 16, 24

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan