- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02239003
NMDA-enhancing Agent for the Treatment of Mild Cognitive Impairment
January 23, 2018 updated by: Chieh-Hsin Lin, Chang Gung Memorial Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
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
-
-
-
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
- 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
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
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: DAOIB
250-1500 mg/day, oral, for 24 weeks
|
|
PLACEBO_COMPARATOR: Placebo
placebo, oral, for 24 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
week 0, 8, 16, 24
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in speed of processing (Category Fluency) at week 24
Time Frame: week 0, 24
|
week 0, 24
|
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
|
week 8, 16, 24
|
Change from baseline in working memory (Wechsler Memory Scale, Spatial Span) at week 24
Time Frame: week 0, 24
|
week 0, 24
|
Change from baseline in verbal learning and memory tests (Wechsler Memory Scale, Word Listing) 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
Investigators
- Principal Investigator: Chieh-Hsin Lin, MD, PhD, Chang Gung Memorial Hospital
- Study Chair: Hsien-Yuan Lane, MD, PhD, China Medical University, China
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)
October 1, 2017
Study Completion (ACTUAL)
December 1, 2017
Study Registration Dates
First Submitted
September 9, 2014
First Submitted That Met QC Criteria
September 10, 2014
First Posted (ESTIMATE)
September 12, 2014
Study Record Updates
Last Update Posted (ACTUAL)
January 24, 2018
Last Update Submitted That Met QC Criteria
January 23, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 103-3642C
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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