NCT03172117CompletedPhase 1
Follow-up Study of Safety and Efficacy in Subjects Who Completed NEUROSTEM® Phase-I/IIa Clinical Trial.
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Medipost Co Ltd.
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Change from the baseline in ADAS-Cog
Study Overview
Brief Summary
A long-term follow-up study to obtain safety and efficacy data in subjects who completed phase 1/2a clinical trial of NEUROSTEM® (NCT02054208), comparing NEUROSTEM and placebo groups for up to 36 months after the initial administration in patients suffering from Alzheimer's disease
Detailed Description
The subjects will be followed up at 12-month, 24-month, and 36-month (phone call) after the initial administration of NEUROSTEM®.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 86 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Assessment of safety and exploratory treatment efficacy in subjects who were enrolled and completed phase 1/2a clinical trial of NEUROSTEM®.
- •Subjects who have been treated with either NEUROSTEM® or placebo at least 12 months ago.
- •Subjects who voluntarily decided to participate and signed the consent form after receiving explanations on the clinical trial (in case it is difficult for the participant to sign, the consent of the legal representative)
Exclusion Criteria
- •Subjects who were not enrolled in phase 1/2a clinical trial of Neurostem® for assessing safety and exploratory treatment efficacy
- •Other subjects, excluding those listed above, who were deemed unsuitable by the PI
Outcomes
Primary Outcomes
Change from the baseline in ADAS-Cog
Time Frame: 24 month after the first dose
Alzheimer's Disease assessment Scale-Cognitive Subscale
Secondary Outcomes
- Change from the baseline in CGA-NPI(24 month after the first dose)
- Change in Florbetaben-PET(24 month after the first dose)
- Change from baseline in MRI (DTI mapping)(24 month after the first dose)
- Change in CDR-SOB(24 month after the first dose)
- Change from the baseline in K-MMSE(24 month after the first dose)
- Change in CIBIC-plus(24 month after the first dose)
- Change in FDG-PET (CMRglc: regional cerebral metabolic rate for glucose)(24 month after the first dose)
- Change from the baseline in S-IADL(24 month after the first dose)
- ADAS-Cog Response Rate(24 month after the first dose)
- Change from the baseline in CSF biomarkers(24 month after the first dose)
Investigators
Study Sites (1)
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