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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02239003 |
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Date of registration:
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09/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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NMDA-enhancing Agent for the Treatment of Mild Cognitive Impairment
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Scientific title:
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Date of first enrolment:
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January 2012 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02239003 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Hsien-Yuan Lane, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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China Medical University, China |
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Name:
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Chieh-Hsin Lin, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chang Gung Memorial Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
50 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Mild Cognitive Impairment
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Intervention(s)
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Drug: Placebo
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Drug: DAOIB
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Change from baseline in verbal learning and memory tests (Wechsler Memory Scale, Word Listing) at week 24
[Time Frame: week 0, 24]
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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]
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Change from baseline in speed of processing (Category Fluency) at week 24
[Time Frame: week 0, 24]
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Change from baseline in working memory (Wechsler Memory Scale, Spatial Span) at week 24
[Time Frame: week 0, 24]
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Secondary ID(s)
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103-3642C
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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