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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01600469
• Other study ID #: 99-2452A3
• Status: Completed
• Phase: Phase 2
• First received: May 14, 2012
• Last updated: June 3, 2013
• Start date: January 2012
• Est. completion date: May 2013

Study information

• Verified date: April 2011
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cognition Disorders
• Mild Cognitive Impairment

Intervention

Drug:
• DAOI-B
250-1500 mg/day, oral, for 24 weeks

Other:
• Placebo
placebo, oral, for 24 weeks

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Alzheimer's disease assessment scale-cognitive subscale in week 8, 16 and 24		Week 0, 8, 16, 24	No
Secondary	Change from baseline in Mini Mental Status Examination at week 8, 16 and 24		Week 0, 8, 16, 24	No
Secondary	Change from baseline in Instrumental Activities of Daily Living at week 8, 16 and 24		Week 0, 8, 16, 24	No
Secondary	Change from baseline in Verbal learning and memory at week 24		Week 0, 24	No
Secondary	Change from baseline in Digit Span subtest of the Wechsler Memory Scale at week 24		Week 0, 24	No