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

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ClinicalTrials.gov Identifier: NCT01600469
Recruitment Status : Completed
First Posted : May 17, 2012
Last Update Posted : June 4, 2013
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Alzheimer's Disease Mild Cognitive Impairment Drug: DAOI-B Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
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
Study Start Date : January 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: DAOI-B Drug: DAOI-B
250-1500 mg/day, oral, for 24 weeks
Placebo Comparator: Placebo Other: Placebo
placebo, oral, for 24 weeks


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Change from baseline in Mini Mental Status Examination at week 8, 16 and 24 [ Time Frame: Week 0, 8, 16, 24 ]
  2. Change from baseline in Instrumental Activities of Daily Living at week 8, 16 and 24 [ Time Frame: Week 0, 8, 16, 24 ]
  3. Change from baseline in Verbal learning and memory at week 24 [ Time Frame: Week 0, 24 ]
  4. Change from baseline in Digit Span subtest of the Wechsler Memory Scale at week 24 [ Time Frame: Week 0, 24 ]

Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01600469     History of Changes
Other Study ID Numbers: 99-2452A3
First Posted: May 17, 2012    Key Record Dates
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
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders