NMDA-enhancing Agent for the Treatment of Mild Cognitive Impairment

Phase 2

Completed

• Conditions: Mild Cognitive Impairment
• Interventions: Drug: DAOIB; Drug: Placebo

• Registration Number: NCT02239003
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

NMDA neurotransmission plays an important role in learning and memory. NMDA receptors were found to decrease in the frontal lobe and hippocampus of mild cognitive impairment. This study is a randomized, double-blind, placebo-controlled drug trial. All subjects will be allocated randomly to 2 groups: (1) NMDA-enhancer: DAOIB group (starting dose: 250-500 mg/d); (2) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOIB may yield better efficacy than placebo for cognitive function in patients with mild cognitive impairment.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2014-09-09
• Study First Submitted QC: 2014-09-10
• Study First Posted: 2014-09-12
• Primary Completion: 2017-10
• Study Completion: 2017-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Clinical diagnosis of mild cognitive impairment
• MMSE between 17-26
• CDR 0.5

Exclusion Criteria

• Hachinski Ischemic Score > 4
• Substance abuse/dependence
• Parkinson disease, epilepsy, dementia with psychotic features
• Major depressive disorder
• Major physical illnesses
• Severe visual or hearing impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DAOIB	DAOIB	250-1500 mg/day, oral, for 24 weeks
Placebo	Placebo	placebo, oral, for 24 weeks

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change from baseline in verbal learning and memory tests (Wechsler Memory Scale, Word Listing) at week 24	week 0, 24
Change from baseline in working memory (Wechsler Memory Scale, Spatial Span) at week 24	week 0, 24
Change from baseline in speed of processing (Category Fluency) at week 24	week 0, 24
Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input at week 8, 16 and 24	week 8, 16, 24

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan