Alzheimer's Disease
Conditions
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®.
Interventions
Low dose: 1 x 10\^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4 week intervals High dose: 3 x 10\^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4 week intervals
OTHERNormal saline 2mL
Normal Saline at 4 week intervals via an Ommaya Reservoir, for a total of 3 administrations
Sponsors
Medipost Co Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 86 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from the baseline in ADAS-Cog | 24 month after the first dose | Alzheimer's Disease assessment Scale-Cognitive Subscale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from the baseline in K-MMSE | 24 month after the first dose | Mini Mental State Exmination Korean version |
| Change from the baseline in CGA-NPI | 24 month after the first dose | Caregiver-administered Neuropsychiatric Inventory |
| ADAS-Cog Response Rate | 24 month after the first dose | the ADAS-cog score at 24 month after the first administration compared to the baseline |
| Change in CDR-SOB | 24 month after the first dose | Clinical Dementia Rating-Sum of Box |
| Change from the baseline in S-IADL | 24 month after the first dose | Seoul Instrumental Activities of Daily Living |
| Change in Florbetaben-PET | 24 month after the first dose | Florbetaben - Pittsburgh Compound B-positron emission tomography |
| Change in FDG-PET (CMRglc: regional cerebral metabolic rate for glucose) | 24 month after the first dose | fluorodeoxyglucose positron emission tomography |
| Change from baseline in MRI (DTI mapping) | 24 month after the first dose | MRI Analysis |
| Change from the baseline in CSF biomarkers | 24 month after the first dose | biomakrer analysis |
| Change in CIBIC-plus | 24 month after the first dose | The Clinician's Interview Based Impression of Change-plus |
Countries
South Korea
Outcome results
None listed