The primary purpose of this study is to evaluate the safety and the efficacy of (Human Umbilical Cord-Derived Mesenchymal Stem Cells) UCMSCs for patients with Alzheimer's disease (AD).
Study Type: Interventional Study Design: Treatment, Parallel Assignment, Double Blind (Subject, Outcomes Assessor), Randomized, Safety/ Efficacy Study Official Title: Multicenter, Randomized, Double-blind, Placebo Controlled Trial of UCMSCs in Subjects With Alzheimer's Disease
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
16
Biological: Human UCMSCs 20 million cells per subject (0.5×10\^6 UCMSCs per kg) intravenous injection Infusion number: 8 (Once every two weeks)
Subjects with Alzheimer's Disease placebo comparator (normal saline) intravenous injection Infusion number: 8 (Once every two weeks)
South China Research Center for Stem Cell and Regenerative Medicine,South China Institute of Biomedicine
Guangzhou, Guangdong, China
Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)Score
A psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis.
Time frame: 36 weeks from post-administration
Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)Score
A psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis.
Time frame: 10 weeks,18 weeks,24 weeks,48weeks from post-administration
Change in Mini-Mental State Examination (MMSE) Score
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.
Time frame: 10 weeks,18 weeks,36 weeks,24 weeks,48weeks from post-administration
Change in Clinician's Interview-Based Impression of Change (CIBIC-plus) Score
Time frame: 10 weeks,18 weeks,24 weeks,36 weeks,48weeks from post-administration
Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) Score
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).
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Time frame: 10 weeks,18 weeks,24 weeks,36 weeks,48weeks from post-administration
Change in Neuropsychiatric Inventory (NPI) Score
The NPI is a well-validated, reliable, multi-item instrument to assess psychopathology and behavior in AD based on interview with the informant.
Time frame: 10 weeks,18 weeks,24 weeks,36 weeks,48weeks from post-administration
Changes in AD Biomarkers
Plasma beta-amyloid proteins will be collected from blood samples obtained.
Time frame: 36 weeks from post-administration