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The goal of this clinical trial is to evaluate safety and potential therapeutic effect of intraveneously administered CB-AC-02 in patients with Alzheimer's Disease.
Subjects will receive either the single or multiple doses of CB-AC-02 to be followed up and evaluated for safety and potential therapeutic effect
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CB-AC-02 | Experimental | Subjects with Alzheimer's disease Intervention: CB-AC-02 |
|
| Placebo | Placebo Comparator | Subjects with Alzheimer's disease Intervention: Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CB-AC-02 | Biological | Stage1: â‘ Group1: CB-AC-02 administration on day 0 â‘¡ Group2: CB-AC-02 administration on day 0 and on week 4 (repeated injection) Stage2 â‘ Arm1: K-MMSE 20~26 CB-AC-02 administration on day 0 and on week 4 (repeated injection) â‘¡ Arm2: K-MMSE 10~19 CB-AC-02 administration on day 0 and on week 4 (repeated injection) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | Number of subjects with treatment-related adverse events. The safety and tolerability of treatment with CB-AC-02 will be assessed by analysis of adverse events, abnormal findings on physical examinations, standard laboratory tests. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from the baseline in K-MMSE Score | K-MMSE, Korean-Mini Mental Status Examination | 48 weeks |
| Change from the baseline of CMRglc analyzed with SPM (statistical parametric mapping) with Brain FDG PET imaging |
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Inclusion Criteria:
Korean male or female at 50+ years of age at the time of screening visit
Diagnosis of Probable Alzheimer disease (probable AD) according to NINCDS-ADRDA criteria at Screening visit
Positive for Amyloid on amyloid-ligand PET
A subject with the imaging findings of Alzheimer's disease as confirmed by MRI or PET
Korea Mini-Mental State Examination (KMMSE) score of 10-26 at time of screening visit
Presence of caregiver who can provide information on the subject's condition
Subject who has been taking stable dose of Alzheimer medication for last 2 months or more
Subject who is informed of the clinical trial and signs a consent form (if unable to sign, a consent from a legally acceptable representative is required)
Exclusion Criteria:
Concurrent Dementia as a result of other disorders [i.e. infectious disease of the central nervous system such as HIV, syphilis, head injury, Creutzfeld-Jacob disease, Picks disease, Huntington's disease, Parkinson's disease, other subdural hematoma, hydrocephalus and structural brain lesions, drug addiction, alcoholism, substance abuse, thyroid disease, parathyroid disease, vitamins and other nutritional deficiencies and vascular etc.]
Subject with vascular dementia as determined by the clinical criteria of DSM-IV and the imaging criteria of Erkinkuntii
Subject with severe white matter hyperintensities (i.e. ≥ 25mm of the deep white matter and ≥ 10mm of the periventricular capping/banding in lengths)
Abnormal laboratory findings at screening visit
Subjects who are positive for HIV, syphilis or active HBV, HCV infection
Subjects in poor medical condition or subjects with severe cardiovascular, gastrointestinal, pulmonary or endocrinologic disease A. Suspected active active lung disease on chest X-ray at screening visit B. Diagnosis of cancer (except for the subjects who remains in complete remission for 5 years or more )
Subject with concurrent unstable psychiatric disorder (i.e. severe depression, or schizophrenia, or bipolar disorder, etc)
Pregnant or lactating women
Women of childbearing age who reject to practice contraception with one of the following methods
Subjects with a history of alcohol abuse (>30g/day) or drug abuse
Subjects who cannot undergo any of the tests performed in this clinical trial (for example, MRI, CT, PET, CSF study)
Subjects with known allergies to protein products (Bovine serum), antibiotics (gentamycin) or DMSO
Subjects whom the principal investigator considers inappropriate for participation in theis study
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| Name | Affiliation | Role |
|---|---|---|
| Hyun Sook Kim | CHA University Bundang Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bundang Medical Center | Seongnam-si | Gyeonggi-do | South Korea |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Placebo | Biological | Stage2: Placebo administration on day 0 and on week 4 (repeated injection) |
|
CMRglc, cerebral metabolic rate for glucose
| 48 weeks |
| Changes from the baseline of Amyloid amount analyzed with SPM with amyloid PET imaging | SPM, statistical parametric mapping | 48 weeks |
| Changes of band power in qEEG | qEEG, Quantitative electroencephalography | 48 weeks |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |