NMDA-enhancing Agent for Treatment of Mild Cognitive Impairment and Mild Alzheimer's Disease

June 3, 2013 updated by: Chang Gung Memorial Hospital
NMDA activation plays an important role in learning and memory. NMDA receptors were found to decrease in the frontal lobe and hippocampus of Alzheimer's disease and mild cognitive function impairment. This study is a randomized, double-blind, placebo-controlled drug trial. All patients will be allocated randomly to 2 groups: (1) NMDA enhancer: DAOI-B group (starting dose: 250-500 mg/d); (2) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOI-B may yield better efficacy than placebo for cognitive function in patients with mild cognitive impairment or mild Alzheimer's disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 886
        • Kaohsiung Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of mild cognitive impairment or mild Alzheimer's
  • MMSE between 17-26
  • CDR 0.5 or 1

Exclusion Criteria:

  • Hachinski Ischemic Score > 4
  • substance abuse/dependence
  • Parkinson disease
  • epilepsy
  • major depressive disorder
  • dementia with psychotic features
  • major physical illnesses
  • severe visual or hearing impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
placebo, oral, for 24 weeks
Experimental: DAOI-B
Drug: DAOI-B
250-1500 mg/day, oral, for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Alzheimer's disease assessment scale-cognitive subscale in week 8, 16 and 24
Time Frame: Week 0, 8, 16, 24
Week 0, 8, 16, 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Mini Mental Status Examination at week 8, 16 and 24
Time Frame: Week 0, 8, 16, 24
Week 0, 8, 16, 24
Change from baseline in Instrumental Activities of Daily Living at week 8, 16 and 24
Time Frame: Week 0, 8, 16, 24
Week 0, 8, 16, 24
Change from baseline in Verbal learning and memory at week 24
Time Frame: Week 0, 24
Week 0, 24
Change from baseline in Digit Span subtest of the Wechsler Memory Scale at week 24
Time Frame: Week 0, 24
Week 0, 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Study Chair: Hsien-yuan Lane, MD, PhD, Departments of Psychiatry, China Medical University Hospital, Taichung, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

May 14, 2012

First Submitted That Met QC Criteria

May 15, 2012

First Posted (Estimate)

May 17, 2012

Study Record Updates

Last Update Posted (Estimate)

June 4, 2013

Last Update Submitted That Met QC Criteria

June 3, 2013

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 99-2452A3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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