Clinical trial NCT03172117: Follow-up Study of Safety and Efficacy in Subjects Who Completed NEUROSTEM® Phase-I/IIa Clinical Trial.
Official title: Follow-up Study of Safety and Efficacy in Subjects Who Completed NEUROSTEM® Phase-I/IIa Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: Medipost Co Ltd.
Sponsor class: INDUSTRY
First posted: 2017-06-01
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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®.

Eligibility criteria: 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

Primary outcomes:
measure: Change from the baseline in ADAS-Cog
timeFrame: 24 month after the first dose
Secondary outcomes:
measure: Change from the baseline in S-IADL
timeFrame: 24 month after the first dose
measure: Change from the baseline in K-MMSE
timeFrame: 24 month after the first dose
measure: Change from the baseline in CGA-NPI
timeFrame: 24 month after the first dose
measure: ADAS-Cog Response Rate
timeFrame: 24 month after the first dose
measure: Change in CDR-SOB
timeFrame: 24 month after the first dose
measure: Change in CIBIC-plus
timeFrame: 24 month after the first dose
measure: Change in Florbetaben-PET
timeFrame: 24 month after the first dose
measure: Change in FDG-PET (CMRglc: regional cerebral metabolic rate for glucose)
timeFrame: 24 month after the first dose
measure: Change from baseline in MRI (DTI mapping)
timeFrame: 24 month after the first dose
measure: Change from the baseline in CSF biomarkers
timeFrame: 24 month after the first dose
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
citation: Kim HJ, Cho KR, Jang H, Lee NK, Jung YH, Kim JP, Lee JI, Chang JW, Park S, Kim ST, Moon SW, Seo SW, Choi SJ, Na DL. Intracerebroventricular injection of human umbilical cord blood mesenchymal stem cells in patients with Alzheimer's disease dementia: a phase I clinical trial. Alzheimers Res Ther. 2021 Sep 14;13(1):154. doi: 10.1186/s13195-021-00897-2.