This is a randomized, double-blind, placebo-controlled, parallel-group comparison study in subjects with Alzheimer's Disease. Following first screening period, subjects will be randomly assigned into one of the following arms: AstroStem and placebo control in a 1:1 ratio. AstroStem or placebo control will be administered via I.V. at Week 0. This procedure will be repeated 9 times at 2-week interval. Subjects will be scheduled for two follow-up visits at Weeks 30 and 52 to evaluate primary and secondary outcome endpoints.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
21
Autologous adipose tissue derived mesenchymal stem cells (AdMSC)
Saline with 30% auto-serum
ATP Clinical Research
Costa Mesa, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
Valden Medical
Honolulu, Hawaii, United States
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
Time frame: 30 Weeks
ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive Subscale)
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
Time frame: Baseline and 30 Weeks
MMSE (Mini-mental Status Examination)
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.
Time frame: Baseline and 30 Weeks
CDR-SOB (Clinical Dementia Rating-Sum of Boxes)
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
Time frame: Baseline and 30 Weeks
NPI (Neuropsychiatric Inventory)
Changes of NPI from baseline at Week 30 Score range: 0-144 higher score indicates higher disturbance.
Time frame: Baseline and 30 Weeks
GDS (Geriatric Depression Scale)
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.
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Time frame: Baseline and 30 Weeks
ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living)
Change of ADCS-ADL from baseline at Week 30 Score range: 0-78 Lower score indicates greater severity.
Time frame: Baseline and 30 Weeks
C-SSRS (Columbia Suicide Severity Rating Scale)
Changes of C-SSRS from baseline at Week 30 Score range: 0-25 Higher score indicates higher severity.
Time frame: Baseline and 30 Weeks