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NMDA-enhancing Agent for the Treatment of Mild Cognitive Impairment

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ClinicalTrials.gov Identifier: NCT02239003
Recruitment Status : Completed
First Posted : September 12, 2014
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Chieh-Hsin Lin, Chang Gung Memorial Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Drug: DAOIB Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : January 2012
Actual Primary Completion Date : October 2017
Actual Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: DAOIB
250-1500 mg/day, oral, for 24 weeks
Drug: DAOIB
Placebo Comparator: Placebo
placebo, oral, for 24 weeks
Drug: Placebo



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Change from baseline in speed of processing (Category Fluency) at week 24 [ Time Frame: week 0, 24 ]
  2. 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 ]
  3. Change from baseline in working memory (Wechsler Memory Scale, Spatial Span) at week 24 [ Time Frame: week 0, 24 ]
  4. 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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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02239003


Locations
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Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Taiwan, 886
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Chieh-Hsin Lin, MD, PhD Chang Gung Memorial Hospital
Study Chair: Hsien-Yuan Lane, MD, PhD China Medical University, China

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Responsible Party: Chieh-Hsin Lin, Dr, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02239003     History of Changes
Other Study ID Numbers: 103-3642C
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders