A Study to Evaluate the Safety and Efficacy of AstroStem in Treatment of Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT03117738|
Recruitment Status : Completed
First Posted : April 18, 2017
Results First Posted : July 9, 2021
Last Update Posted : August 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Drug: AstroStem Other: Placebo-Control||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AstroStem, Autologous Adipose Tissue Derived Mesenchymal Stem Cells, in Patients With Alzheimer's Disease|
|Actual Study Start Date :||May 9, 2017|
|Actual Primary Completion Date :||June 26, 2019|
|Actual Study Completion Date :||August 31, 2019|
Autologous adipose tissue derived mesenchymal stem cells (AdMSC)
|Placebo Comparator: Placebo-Control||
Saline with 30% auto-serum
- Treatment Related Adverse Events [ Time Frame: 30 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
- ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive Subscale) [ Time Frame: Baseline and 30 Weeks ]Change of ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive subscale) from Baseline at Week 30 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 30 Weeks ]Change of MMSE from baseline at Week 30 Score range: 0-30 A score of 20 to 24 suggests mild dementia, 13 to 20 suggests moderate dementia, and less than 12 indicates severe dementia.
- CDR-SOB (Clinical Dementia Rating-Sum of Boxes) [ Time Frame: Baseline and 30 Weeks ]Changes of CDR-SOB from baseline at Week 30 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
- NPI (Neuropsychiatric Inventory) [ Time Frame: Baseline and 30 Weeks ]Changes of NPI from baseline at Week 30 Score range: 0-144 higher score indicates higher disturbance.
- GDS (Geriatric Depression Scale) [ Time Frame: Baseline and 30 Weeks ]Changes of GDS from baseline at Week 30 Score range: 0-15 Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
- ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living) [ Time Frame: Baseline and 30 Weeks ]Change of ADCS-ADL from baseline at Week 30 Score range: 0-78 Lower score indicates greater severity.
- C-SSRS (Columbia Suicide Severity Rating Scale) [ Time Frame: Baseline and 30 Weeks ]Changes of C-SSRS from baseline at Week 30 Score range: 0-25 Higher score indicates higher severity.
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): NCT03117738
|United States, California|
|ATP Clinical Research|
|Costa Mesa, California, United States, 92626|
|Syrentis Clinical Research|
|Santa Ana, California, United States, 92705|
|United States, Hawaii|
|Honolulu, Hawaii, United States, 96817|