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

Primary Purpose

Alzheimer's Disease, Mild Cognitive Impairment

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
DAOI-B
Placebo
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease, mild cognitive impairment, NMDA

Eligibility Criteria

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

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

Sites / Locations

  • Kaohsiung Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DAOI-B

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 14, 2012
Last Updated
June 3, 2013
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01600469
Brief Title
NMDA-enhancing Agent for Treatment of Mild Cognitive Impairment and Mild Alzheimer's Disease
Official Title
NMDA-enhancing Agent for Treatment of Mild Cognitive Impairment and Mild Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Mild Cognitive Impairment
Keywords
Alzheimer's disease, mild cognitive impairment, NMDA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DAOI-B
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DAOI-B
Intervention Description
250-1500 mg/day, oral, for 24 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
placebo, oral, for 24 weeks
Primary Outcome Measure Information:
Title
Change from baseline in Alzheimer's disease assessment scale-cognitive subscale in week 8, 16 and 24
Time Frame
Week 0, 8, 16, 24
Secondary Outcome Measure Information:
Title
Change from baseline in Mini Mental Status Examination at week 8, 16 and 24
Time Frame
Week 0, 8, 16, 24
Title
Change from baseline in Instrumental Activities of Daily Living at week 8, 16 and 24
Time Frame
Week 0, 8, 16, 24
Title
Change from baseline in Verbal learning and memory at week 24
Time Frame
Week 0, 24
Title
Change from baseline in Digit Span subtest of the Wechsler Memory Scale 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
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsien-yuan Lane, MD, PhD
Organizational Affiliation
Departments of Psychiatry, China Medical University Hospital, Taichung, Taiwan
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

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

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