NMDA Enhancer for the Treatment of Mild Alzheimer's Disease

Phase 2

Completed

• Conditions: Alzheimer Disease
• Interventions: Drug: DAOI-A group; Drug: DAOI-B group; Drug: DAOI-C group; Drug: Placebo oral capsule

• Registration Number: NCT03752463
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

NMDA neurotransmission plays an important role in learning and memory. NMDA receptors (NMDAR) were found to decrease in the frontal lobe and hippocampus of Alzheimer's disease (AD). This study is a randomized, double-blind, placebo controlled drug trial for testing the efficacy of NMDAR-enhancer. All subjects will be allocated randomly to 4 groups: (1) DAOI-A group; (2) DAOI-B group; (3) DAOI-C group; (4) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOI may yield better efficacy than placebo for cognitive function in patients with AD.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-22
• Study First Submitted: 2018-11-21
• Study First Submitted QC: 2018-11-21
• Study First Posted: 2018-11-26
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

• Clinical diagnosis of Alzheimer's disease
• MMSE between 10-26
• CDR 1

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
DAOI-A group	DAOI-A group	-
DAOI-B group	DAOI-B group	-
DAOI-C group	DAOI-C group	-
Placebo group	Placebo oral capsule	-

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	Cognitive assessment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan