Safety and Exploratory Efficacy Study of UCMSCs in Patients With Alzheimer's Disease (SEESUPAD)
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|ClinicalTrials.gov Identifier: NCT02672306|
Recruitment Status : Not yet recruiting
First Posted : February 3, 2016
Last Update Posted : February 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Biological: UCMSCs Biological: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Safety and Exploratory Efficacy Study of UCMSCs in Patients With Alzheimer's Disease|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2019|
Subjects with Alzheimer's Disease Intervention: UCMSCs
Biological: Human UCMSCs 20 million cells per subject (0.5×10^6 UCMSCs per kg) intravenous injection Infusion number: 8 (Once every two weeks)
Other Name: Human Umbilical Cord Derived Mesenchymal
Placebo Comparator: Placebo
Subjects with Alzheimer's Disease Intervention: Placebo (normal saline)
Subjects with Alzheimer's Disease placebo comparator (normal saline) intravenous injection Infusion number: 8 (Once every two weeks)
Other Name: Normal saline
- Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)Score [ Time Frame: 10 weeks from post-administration ]A psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis.
- Change in Alzheimer's Disease Cooperative Study Clinician's Global Impression of Change (ADCS-CCGIC) Score [ Time Frame: 10 weeks from post-administration ]A systematic method for assessing clinically significant change in a clinical trial as viewed by an independent skilled and experienced clinician . The ADCS-CGIC focuses on clinician's observations of change in the subject's cognitive, functional, and behavioral performance since the beginning of a trial. It relies on both direct examination of the subject and an interview of an informant. Unlike a targeted symptom scale, it takes into account a subject's overall function in the cognitive, behavioral, and functional activity domains.
- Change in Mini-Mental State Examination (MMSE) Score [ Time Frame: 10 weeks from post-administration ]A frequently used screening instrument for Alzheimer's disease drug studies. It evaluates orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons
- Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) Score [ Time Frame: 10 weeks from post-administration ]ADCS-ADL assesses functional performance in subjects with Alzheimer's disease. In a structured interview format, informants are queried as to whether subjects attempted each item in the inventory during the prior 4 weeks and their level of performance. The ADCS-ADL scale discriminates well between normal controls and mild AD patients. It has good test-retest reliability. The ADCS-ADL includes some items from traditional basic ADL scales (e.g., grooming, dressing, walking, bathing, feeding, toileting) as well as items from instrumental activities of daily living scales (e.g., shopping, preparing meals, using household appliances, keeping appointments, reading).
- Change in Neuropsychiatric Inventory (NPI) Score [ Time Frame: 10 weeks from post-administration ]The NPI is a well-validated, reliable, multi-item instrument to assess psychopathology and behavior in AD based on interview with the informant.
- Changes in AD Biomarkers [ Time Frame: 10 weeks from post-administration ]Plasma beta-amyloid proteins will be collected from blood samples obtained.
- Change from the baseline in cerebrospinal fluid (CSF) biomarkers [ Time Frame: 10 weeks from post-administration ]Amyloid beta and tau will be collected from CSF obtained.
- Symptoms Checklist and Adverse Event Assessment [ Time Frame: 10 weeks ]Adverse events and symptoms checklist are used to monitor signs or symptoms that may or may not be related to study medication, abnormalities detected during physical examination, or clinical significant laboratory abnormalities.
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): NCT02672306
|Contact: Xuetao Pei, M.D., Ph.D||8610-68164807||AMMS0906@163.com|
|Contact: Yali Jia, Ph.Dfirstname.lastname@example.org|