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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01600469
First Posted: May 17, 2012
Last Update Posted: June 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
  Purpose
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.

Condition Intervention Phase
Alzheimer's Disease Mild Cognitive Impairment Drug: DAOI-B Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: NMDA-enhancing Agent for Treatment of Mild Cognitive Impairment and Mild Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • 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 Measures:
  • Change from baseline in Mini Mental Status Examination at week 8, 16 and 24 [ Time Frame: Week 0, 8, 16, 24 ]
  • Change from baseline in Instrumental Activities of Daily Living at week 8, 16 and 24 [ Time Frame: Week 0, 8, 16, 24 ]
  • Change from baseline in Verbal learning and memory at week 24 [ Time Frame: Week 0, 24 ]
  • Change from baseline in Digit Span subtest of the Wechsler Memory Scale at week 24 [ Time Frame: Week 0, 24 ]

Enrollment: 86
Study Start Date: January 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DAOI-B Drug: DAOI-B
250-1500 mg/day, oral, for 24 weeks
Placebo Comparator: Placebo Other: Placebo
placebo, oral, for 24 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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): NCT01600469


Locations
Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Taiwan, 886
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Study Chair: Hsien-yuan Lane, MD, PhD Departments of Psychiatry, China Medical University Hospital, Taichung, Taiwan
  More Information

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01600469     History of Changes
Other Study ID Numbers: 99-2452A3
First Submitted: May 14, 2012
First Posted: May 17, 2012
Last Update Posted: June 4, 2013
Last Verified: April 2011

Keywords provided by Chang Gung Memorial Hospital:
Alzheimer's disease
mild cognitive impairment
NMDA

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Mild Cognitive Impairment
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders