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NMDA Enhancer for the Treatment of Mild Alzheimer's Disease

Primary Purpose

Alzheimer Disease

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

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of Alzheimer's disease
  • MMSE between 10-26
  • CDR 1

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 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

DAOI-A group

DAOI-B group

DAOI-C group

Placebo group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 21, 2018
Last Updated
August 24, 2021
Sponsor
Chang Gung Memorial Hospital
Collaborators
Ministry of Science and Technology, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT03752463
Brief Title
NMDA Enhancer for the Treatment of Mild Alzheimer's Disease
Official Title
NMDA Enhancer for the Treatment of Mild Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 22, 2015 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
Ministry of Science and Technology, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
NMDA neurotransmission plays an important role in learning and memory. NMDA receptors (NMDAR) were found to decrease in the frontal lobe and hippocampus of Alzheimer's disease (AD). This study is a randomized, double-blind, placebo controlled drug trial for testing the efficacy of NMDAR-enhancer. All subjects will be allocated randomly to 4 groups: (1) DAOI-A group; (2) DAOI-B group; (3) DAOI-C group; (4) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOI may yield better efficacy than placebo for cognitive function in patients with AD.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
DAOI-A group
Arm Type
Experimental
Arm Title
DAOI-B group
Arm Type
Experimental
Arm Title
DAOI-C group
Arm Type
Experimental
Arm Title
Placebo group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DAOI-A group
Intervention Description
DAOI with A dose
Intervention Type
Drug
Intervention Name(s)
DAOI-B group
Intervention Description
DAOI with B dose
Intervention Type
Drug
Intervention Name(s)
DAOI-C group
Intervention Description
DAOI with C dose
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24
Description
Cognitive assessment
Time Frame
week 0, 8, 16, 24
Secondary Outcome Measure Information:
Title
Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input at week 8, 16 and 24
Description
Global assessment
Time Frame
week 8, 16, 24
Title
Change from baseline in speed of processing (Category Fluency) at week 24
Description
Cognitive assessment
Time Frame
week 0, 24
Title
Change from baseline in working memory (Wechsler Memory Scale, Spatial Span) at week 24
Description
Cognitive assessment
Time Frame
week 0, 24
Title
Change from baseline in verbal learning and memory tests (Wechsler Memory Scale, Word Listing) at week 24
Description
Cognitive assessment
Time Frame
week 0, 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of Alzheimer's disease MMSE between 10-26 CDR 1 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
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 Enhancer for the Treatment of Mild Alzheimer's Disease

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