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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer's Disease Mild Cognitive Impairment | Drug: DAOI-B Other: Placebo | Phase 2 |
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 |

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
|
- Change from baseline in Alzheimer's disease assessment scale-cognitive subscale in week 8, 16 and 24 [ Time Frame: Week 0, 8, 16, 24 ]
- 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 ]

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

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
Taiwan | |
Kaohsiung Chang Gung Memorial Hospital | |
Kaohsiung, Taiwan, 886 |
Study Chair: | Hsien-yuan Lane, MD, PhD | Departments of Psychiatry, China Medical University Hospital, Taichung, Taiwan |
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 |