Study to Evaluate the Safety and Efficacy of AstroStem in Treatment of Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT04482413|
Recruitment Status : Not yet recruiting
First Posted : July 22, 2020
Last Update Posted : September 28, 2022
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Drug: AstroStem Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of AstroStem, Autologous Adipose Tissue Derived Mesenchymal Stem Cells, in Patients With Alzheimer's Disease|
|Estimated Study Start Date :||February 1, 2023|
|Estimated Primary Completion Date :||May 30, 2024|
|Estimated Study Completion Date :||December 20, 2024|
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.
Treatment group receive AstroStem(Autologous adipose tissue derived mesenchymal stem cells, AdMSCs) every 4 weeks from Week 0 to Week 36.
Placebo Comparator: Placebo Control
Placebo control group will receive AstroStem Placebo.
Placebo control group receive 20 mL of Saline and auto serum every 4 weeks from Week 0 to Week 36.
Other Name: AstroStem Placebo
- SUVR (Standard Uptake Value Ratio) [ Time Frame: Baseline and 52 Weeks ]Standard Uptake Value Ratio (SUVR) of the Amyloid PET scan
- CDR-SB score (Clinical Dementia Rating Sum of Boxes) [ Time Frame: Baseline and 52 Weeks ]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
- ADAS-Cog-11 score (Alzheimer's Disease assessment Scale-Cognitive Subscale (11 items)) [ Time Frame: Baseline and 52 Weeks ]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
- MMSE (Mini-mental status examination) [ Time Frame: Baseline and 52 Weeks ]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.
- ADCS-ADL-MCI (Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory) [ Time Frame: Baseline and 52 Weeks ]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
- C-SSRS (Columbia Suicide Severity Rating Scale) [ Time Frame: Baseline and 52 Weeks ]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.
- NPI (Neuropsychiatric Inventory) [ Time Frame: Baseline and 52 Weeks ]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).
- Treatment related Adverse Events [ Time Frame: Baseline and 52 Weeks ]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
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): NCT04482413
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