NMDA-enhancing Agent for the Treatment of Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02239003
• Other study ID #: 103-3642C
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2014
• Last updated: January 23, 2018
• Start date: January 2012
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Drug:
• DAOIB

• Placebo

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

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