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| Name | Class |
|---|---|
| Guangzhou General Hospital of Guangzhou Military Command | OTHER |
| Third Affiliated Hospital, Sun Yat-Sen University | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UCMSCs | Experimental | Subjects with Alzheimer's Disease Intervention: UCMSCs |
|
| Placebo | Placebo Comparator | Subjects with Alzheimer's Disease Intervention: Placebo (normal saline) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCMSCs | Biological | Biological: Human UCMSCs 20 million cells per subject (0.5×10^6 UCMSCs per kg) intravenous injection Infusion number: 8 (Once every two weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)Score | A psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis. | 36 weeks from post-administration |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)Score | A psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis. | 10 weeks,18 weeks,24 weeks,48weeks from post-administration |
| Change in Mini-Mental State Examination (MMSE) Score |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms Checklist and Adverse Event Assessment | 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. | From Day0(administration)to 48 weeks post-administration. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South China Research Center for Stem Cell and Regenerative Medicine,South China Institute of Biomedicine | Guangzhou | Guangdong | 510320 | China |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Placebo | Biological | Subjects with Alzheimer's Disease placebo comparator (normal saline) intravenous injection Infusion number: 8 (Once every two weeks) |
|
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. |
| 10 weeks,18 weeks,36 weeks,24 weeks,48weeks from post-administration |
| Change in Clinician's Interview-Based Impression of Change (CIBIC-plus) Score | 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). | 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. | 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. | 36 weeks from post-administration |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |