Alzheimer Disease, Brain Diseases, Central Nervous System Diseases, Delirium, Dementia, Amnestic, Cognitive Disorders, Dementia, Mental Disorders, Nervous System Diseases, Neurodegenerative Diseases, Tauopathies
Conditions
Keywords
Alzheimer, Mesenchymal Stem Cells, Umbilical Cord Blood
Brief summary
The purpose of the study is to determine the long-term safety and exploratory efficacy of NEUROSTEM®-AD, administered via an open brain surgery to subjects with dementia of the Alzheimer's type, who were eligible for and enrolled in the earlier part of the phase I. Aside from the subjects who completed the earlier part of the Phase I, 3 additional subjects with comparable demographics and disease characteristics as the treatment group will be enrolled into a control group, followed-up for 3 months, and compared for various disease progression indicators with the treatment group. The hypothesis is that NEUROSTEM®-AD is safe and effective in the treatment of dementia of the Alzheimer's type.
Detailed description
This is a long-term follow up study of the earlier part of the phase I, during which the safe and effective dose(safety) of NEUROSTEM®-AD was determined for implantation into the brains of subjects with Dementia of the Alzheimer's type. Subjects with Dementia of the Alzheimer's type, who signed the informed consent form and meet the eligibility criteria, were implanted with a single dose of NEUROSTEM®-AD, hUBC-MSCs, into the brain. The subjects were hospitalized for 5 to 10 days following the surgical implantation and were observed for acute adverse events: Gradient echo MRI within the the 24 hours post-op, vital signs, clinical laboratory tests, chest x-rays within Day 2. On Day 14, DLT was assessed, and the subjects were followed up on the safety and disease progression of dementia (of the Alzheimer's type) for 12 weeks post-implantation. In this part of the study, the subjects described above will be followed-up for upto Month 24, and 3 additional subjects with comparable demographics and disease characteristics as the treatment group (refer to Inclusion/Exclusion Criteria) will be enrolled as a control group, followed up for 3 months and compared with the treatment group for various indicators of the disease progression.
Interventions
BIOLOGICALNEUROSTEM®-AD
NEUROSTEM®-AD was administered to eligible subjects in the early part of the Phase I clinical study. In this follow-up study, no intervention will be performed.
Sponsors
Medipost Co Ltd.
Duk Lyul Na
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
TEST GROUP Inclusion Criteria: * Subjects who have enrolled and completed the Phase I cliical trial: The Safety and The Efficacy Evaluation of NEUROSTEM®-AD in Patients With Alzheimer's Disease * Subjects who are willing to participate in the study and sign the consent form
Exclusion criteria
* Females who are pregnant or nursing * Subjects who have participated in another clinical study within the 3 months prior to the initiation of this study * Subjects who are restricted from undergoing exams perfomed during the study (i.e. MRI, CT, or PET screening) * Subjects who the principal investigator considers inappropriate for participation in the study due to any reasons other than those listed above CONTROL GROUP Inclusion Criteria: * Patients with a moderate alzheimer's disease, diagnosed with a dementia of alzheimer's type, according to the DSM-VI and NINCDS-ADRDA criteria, and shows amyloid-positive in a PIB-PET
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | upto 24 months post-op | Incidence rate ot adverse events (vital signs, physical examination, mixed lymphocyte reaction, and laboratory tests) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | upto 24 months post-op | Primary Efficacy Variable: ADAS-cog response rate, ADAS-cog response is defined as when ADAS-cog score at the end of the study is not worse than the Baseline score. Secondary Efficacy Variables: * Changes in Seoul Instrumental Activities of Daily Living (S-IADL) * Changes in Mini Mental State Examination Korean verson (K-MMSE) * Changes in Caregiver-administered Neuropsuchiatric Inventory * Changes in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) * Changes in CMRglc: regional cerebral metabolic rate for glucose (FDG-PET) |
Countries
South Korea
Contacts
Primary ContactDuk-Lyul Na, MD, PhD
Outcome results
None listed