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 (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:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

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 ]

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


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

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


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

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

ClinicalTrials.gov processed this record on June 23, 2017

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