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This is a phase 2b randomized, double-blind, Placebo-controlled study with 2 treatment arms, to compare the efficacy and safety of AstroStem vs. Placebo treatment in patients with mild Alzheimer's Disease(AD). Eligible patients diagnosed with AD within one year of the start of treatment will be enrolled. Patients who are randomized into the treatment group will be administered via intravenously AstroStem every 4 weeks from Week 0 to Week 36. On the other hand, patients who are randomized into the placebo control group will receive Placebo every 4 weeks from Week 0 to Week 36. After the final administration, patients will be scheduled for two follow-up visits, at Weeks 44 and 52, to assess efficacy and safety endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Treatment group will be administered via intravenously AstroStem which consists of two syringes and each syringe contains 2.0 x 10^8 cells / 20 mL of saline with 30% auto-serum. |
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| Placebo Control | Placebo Comparator | Placebo control group will receive AstroStem Placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AstroStem | Drug | Treatment group receive AstroStem(Autologous adipose tissue derived mesenchymal stem cells, AdMSCs) every 4 weeks from Week 0 to Week 36. |
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| Measure | Description | Time Frame |
|---|---|---|
| SUVR (Standard Uptake Value Ratio) | Standard Uptake Value Ratio (SUVR) of the Amyloid PET scan | Baseline and 52 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| CDR-SB score (Clinical Dementia Rating Sum of Boxes) | Changes of CDR-SOB from baseline at Week 52 Score range: 0-18.0 0 = normal, 0.5-4.0 = questionable cognitive dementia, 4.5-9.0 = mild dementia, 9.5-15.5 = moderate dementia, and 16.0-18.0 = severe dementia | Baseline and 52 Weeks |
| ADAS-Cog-11 score (Alzheimer's Disease assessment Scale-Cognitive Subscale (11 items)) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hugh Lee | Contact | 301-540-2600 | hughlee@kcrnresearch.com |
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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 | Drug | Placebo control group receive 20 mL of Saline and auto serum every 4 weeks from Week 0 to Week 36. |
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Change of ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive subscale) from Baseline at Week 52 Score range: 0-70 A score of 70 represents the most severe impairment and 0 represents the least impairment |
| Baseline and 52 Weeks |
| MMSE (Mini-mental status examination) | Change from baseline to Week 52 in the Mini-mental status examination (MMSE) score. The Mini-Mental State Exam (MMSE) is a widely used test of cognitive function among the elderly; it includes tests of orientation, attention, memory, language and visual-spatial skills. The Mini-Mental State Examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. | Baseline and 52 Weeks |
| ADCS-ADL-MCI (Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory) | Change from baseline to Week 52 in the ADCS-ADl MCI 0-53 A score of 0 represents the most severe impairment and 53 represents the least impairment | Baseline and 52 Weeks |
| C-SSRS (Columbia Suicide Severity Rating Scale) | Change from baseline to Week 52 in the Columbia Suicide Severity Rating Scale (C-SSRS) score. The suicidal ideation severity subscale ranges from 1 to 5 (with higher number indicating more severe ideation). The intensity of ideation subscale includes 5 questions each one ranging from 1 to 5 (with higher number indicating more intense ideation). The suicidal behavior subscale includes 4 yes/no questions. The suicidal behavior lethality subscale inquires about the level of actual or potential medical damage. | Baseline and 52 Weeks |
| NPI (Neuropsychiatric Inventory) | Change from baseline to Week 52 in the Neuropsychiatric Inventory (NPI) score. The NPI is a structured interview with a caregiver or qualified study partner (defined as having direct contact > 2 days/week) that evaluates both presence and severity of 12 neuropsychiatric features which include: delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability, lability, apathy, aberrant motor behavior, night-time behavior, and appetite/ eating changes. If the response to the domain question is "No", the informant goes to the next question. If "Yes", the informant then rates both the Severity of the symptoms present within the last month on a 3-point scale ranging from 1 to 3 (mild to severe). | Baseline and 52 Weeks |
| Treatment related Adverse Events | Number of subjects with treatment related adverse events as assessed by analysis of adverse events including symptoms, and abnormal findings on physical examination, vital signs, ECG, and standard laboratory examination results | Baseline and 52 Weeks |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |