NMDA Enhancer for the Treatment of Mild Alzheimer's Disease

Alzheimer Disease Clinical Trial

Official title:

NMDA Enhancer for the Treatment of Mild Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03752463
• Other study ID #: 105-3412C
• Status: Completed
• Phase: Phase 2
• Start date: May 22, 2015
• Est. completion date: July 31, 2021

Study information

• Verified date: August 2021
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• DAOI-A group
DAOI with A dose
• DAOI-B group
DAOI with B dose
• DAOI-C group
DAOI with C dose
• Placebo oral capsule
Placebo

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24	Cognitive assessment	week 0, 8, 16, 24
Secondary	Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input at week 8, 16 and 24	Global assessment	week 8, 16, 24
Secondary	Change from baseline in speed of processing (Category Fluency) at week 24	Cognitive assessment	week 0, 24
Secondary	Change from baseline in working memory (Wechsler Memory Scale, Spatial Span) at week 24	Cognitive assessment	week 0, 24
Secondary	Change from baseline in verbal learning and memory tests (Wechsler Memory Scale, Word Listing) at week 24	Cognitive assessment	week 0, 24