NMDA-enhancing Agent for the Treatment of Mild Cognitive Impairment

• Sponsor: Chang Gung Memorial Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02239003
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 71
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Impairment	Drug: DAOIB; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Oct 1, 2017
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DAOIB 250-1500 mg/day, oral, for 24 weeks	Drug: DAOIB
Placebo Comparator: Placebo placebo, oral, for 24 weeks	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. 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

1. Change from baseline in speed of processing (Category Fluency) at week 24 [week 0, 24]

2. Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input at week 8, 16 and 24 [week 8, 16, 24]

3. Change from baseline in working memory (Wechsler Memory Scale, Spatial Span) at week 24 [week 0, 24]

4. Change from baseline in verbal learning and memory tests (Wechsler Memory Scale, Word Listing) at week 24 [week 0, 24]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung		Taiwan	886

Sponsors and Collaborators

• Chang Gung Memorial Hospital

Investigators

• Principal Investigator: Chieh-Hsin Lin, MD, PhD, Chang Gung Memorial Hospital
• Study Chair: Hsien-Yuan Lane, MD, PhD, China Medical University, China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chieh-Hsin Lin, Dr, Chang Gung Memorial Hospital
• ClinicalTrials.gov Identifier: NCT02239003
• Other Study ID Numbers: 103-3642C
• First Posted: Sep 12, 2014
• Last Update Posted: Jan 24, 2018
• Last Verified: Jan 1, 2018

• Additional relevant MeSH terms: Cognitive Dysfunction

Study Results

No Results Posted as of Jan 24, 2018