Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01600469
First received: May 14, 2012
Last updated: June 3, 2013
Last verified: April 2011
History of Changes
  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: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in Mini Mental Status Examination at week 8, 16 and 24 [ Time Frame: Week 0, 8, 16, 24 ] [ Designated as safety issue: No ]
  • Change from baseline in Instrumental Activities of Daily Living at week 8, 16 and 24 [ Time Frame: Week 0, 8, 16, 24 ] [ Designated as safety issue: No ]
  • Change from baseline in Verbal learning and memory at week 24 [ Time Frame: Week 0, 24 ] [ Designated as safety issue: No ]
  • Change from baseline in Digit Span subtest of the Wechsler Memory Scale at week 24 [ Time Frame: Week 0, 24 ] [ Designated as safety issue: No ]
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
Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01600469     History of Changes
Other Study ID Numbers: 99-2452A3
Study First Received: May 14, 2012
Last Updated: June 3, 2013
Health Authority: Taiwan: Department of Health

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
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
 Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on March 01, 2015