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NMDA-enhancing Agent for the Treatment of Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

Status

Completed

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

DAOIB

Placebo

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Kaohsiung Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DAOIB

Placebo

Arm Description

250-1500 mg/day, oral, for 24 weeks

placebo, oral, for 24 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline in speed of processing (Category Fluency) at week 24

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

Change from baseline in working memory (Wechsler Memory Scale, Spatial Span) at week 24

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

Full Information

NCT ID

NCT02239003

First Posted

September 9, 2014

Last Updated

January 23, 2018

Sponsor

Chang Gung Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02239003

Brief Title

NMDA-enhancing Agent for the Treatment of Mild Cognitive Impairment

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

October 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chang Gung Memorial Hospital

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DAOIB

Arm Type

Experimental

Arm Description

250-1500 mg/day, oral, for 24 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

placebo, oral, for 24 weeks

Intervention Type

Drug

Intervention Name(s)

DAOIB

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

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

Time Frame

week 0, 8, 16, 24

Secondary Outcome Measure Information:

Title

Change from baseline in speed of processing (Category Fluency) at week 24

Time Frame

week 0, 24

Title

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

Time Frame

week 8, 16, 24

Title

Change from baseline in working memory (Wechsler Memory Scale, Spatial Span) at week 24

Time Frame

week 0, 24

Title

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

Time Frame

week 0, 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chieh-Hsin Lin, MD, PhD

Organizational Affiliation

Chang Gung Memorial Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hsien-Yuan Lane, MD, PhD

Organizational Affiliation

China Medical University, China

Official's Role

Study Chair

Facility Information:

Facility Name

Kaohsiung Chang Gung Memorial Hospital

City

Kaohsiung

ZIP/Postal Code

886

Country

Taiwan

12. IPD Sharing Statement

Learn more about this trial

NMDA-enhancing Agent for the Treatment of Mild Cognitive Impairment

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