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Evaluation of the Safety and Potential Therapeutic Effects After Intravenous Transplantation of CB-AC-02 in Patients With Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT02899091
Recruitment Status : Recruiting
First Posted : September 14, 2016
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
CHABiotech CO., Ltd

Brief Summary:
The objective of the study is to evaluate the safety and the potential therapeutic effects of CB-AC-02 Intravenous Transplantation in patients with Alzheimer' disease comprised of 2 treatment cohorts:

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Biological: CB-AC-02 Biological: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Phase I / IIa Clinical Trial for Evaluation of Safety and Potential Therapeutic Effect After Transplantation of CB-AC-02 in Patients With Alzheimer's Disease
Actual Study Start Date : September 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CB-AC-02
Subjects with Alzheimer's disease Intervention: CB-AC-02
Biological: CB-AC-02

Stage1:

① Group1: CB-AC-02, 2.0 x 10^8 cells on day 0

② Group2: CB-AC-02, 2.0 x 10^8 cells, on day 0 and on week 4 (repeated injection)

Stage2

① Arm1: K-MMSE 20~26 CB-AC-02, 2.0 x 10^8 cells on day 0 and on week 4 (repeated injection)

② Arm2: K-MMSE 10~19 CB-AC-02, 2.0 x 10^8 cells on day 0 and on week 4 (repeated injection)


Placebo Comparator: Placebo
Subjects with Alzheimer's disease Intervention: Placebo
Biological: Placebo

Stage2:

Placebo on day 0 and on week 4 (repeated injection)





Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: 48 weeks ]

    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.



Secondary Outcome Measures :
  1. Changes from the baseline in ADAS-Cog (Azheimer's disease Assessment Scale - Congintive Subscale) Score [ Time Frame: 48 weeks ]
  2. Changes from the baseline in K-MMSE (Korean-Mini Mental Status Examination) Score [ Time Frame: 48 weeks ]
  3. Changes from the baseline in GDS (Global Deterioration Scale) [ Time Frame: 48 weeks ]
  4. Changes from the baseline in CDR (Clinical Dementia Rating) Score [ Time Frame: 48 weeks ]
  5. Changes from the baseline in K-IADL (Korean Instrumental Activities of Daily Living) Score [ Time Frame: 48 weeks ]
  6. Changes from the baseline in CGA-NPI (Caregiver Administered-Neuropsychiatric Inventory) Score [ Time Frame: 48 weeks ]
  7. Change in CIBIC (Clinician Interview Based Impression of Change)-plus [ Time Frame: 48 weeks ]
  8. Changes from the baseline in SF-36 [ Time Frame: 48 weeks ]
  9. Changes in Amyloid Beta and Tau amount (pg/mL) in CSF (Cerebrospinal fluid) [ Time Frame: 48 weeks ]
  10. Change in Brain MRI (Magnetic Responance imaging) [ Time Frame: 48 weeks ]
  11. Change from the baseline of CMRglc (cerebral metabolic rate for glucose ) analyzed with SPM (statistical parametric mapping) with Brain FDG PET imaging [ Time Frame: 48 weeks ]
  12. Changes from the baseline of Amyloid amount analyzed with SPM (statistical parametric mapping) with amyloid PET imaging [ Time Frame: 48 weeks ]
  13. Changes of band power in qEEG (Quantitative electroencephalography) [ Time Frame: 48 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Korean male or female at 50+ years of age at the time of screening visit
  2. Diagnosis of Probable Alzheimer disease (probable AD) according to NINCDS-ADRDA criteria at Screening visit
  3. Positive for Amyloid on amyloid-ligand PET
  4. A subject with the imaging findings of Alzheimer's disease as confirmed by MRI or PET

    • Presence of brain atrophy on brain MRI by visual assessment
    • Presence of reduced brain glucose metabolism in bilateral temporal-parietal lobe on FDG-PET
  5. Korea Mini-Mental State Examination (KMMSE) score of 10-26 at time of screening visit
  6. Presence of caregiver who can provide information on the subject's condition
  7. Subject who has been taking stable dose of Alzheimer medication for last 2 months or more
  8. 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:

  1. 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.]
  2. Subject with vascular dementia as determined by the clinical criteria of DSM-IV and the imaging criteria of Erkinkuntii
  3. Subject with severe white matter hyperintensities (i.e. ≥ 25mm of the deep white matter and ≥ 10mm of the periventricular capping/banding in lengths)
  4. Abnormal laboratory findings at screening visit:

    A. ALT or AST ≥ 2.5 times the upper limit of normal value

    B. Serum creatinine ≥ 1.5 times the upper limit of normal value

    C. Total bilirubin ≥ 2 times the upper limit of normal value

    D. Total WBC counts < 3,000/㎣

    E. Hemoglobin <9.5g/dL in men or <9.0g/dL in women

    F. Platelet count < 150,000/㎣ at screening visit

    G. PT (INR) ≥ 1.5 or aPTT ≥ 1.5 times the upper limit of normal value

  5. Subjects who are positive for HIV, syphilis or active HBV, HCV infection
  6. 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 )
  7. Subject with concurrent unstable psychiatric disorder (i.e. severe depression, or schizophrenia, or bipolar disorder, etc)
  8. Pregnant or lactating women
  9. Women of childbearing age who reject to practice contraception with one of the following methods

    • Use a condom
    • Use of contraceptive (oral, dermal, or injectable)
    • Use an intra-uterine contraceptive device
  10. Subjects with a history of alcohol abuse (>30g/day) or drug abuse
  11. Subjects who cannot undergo any of the tests performed in this clinical trial (for example, MRI, CT, PET, CSF study)
  12. Subjects with known allergies to protein products (Bovine serum), antibiotics (gentamycin) or DMSO
  13. Subjects whom the principal investigator considers inappropriate for participation in theis study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02899091


Contacts
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Contact: Hye Sun Kim +82-31-881-7431 goldfish79@chamc.co.kr

Locations
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Korea, Republic of
Bundang Medical Center Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of
Contact: HyunSook Kim, MD, PhD         
Sponsors and Collaborators
CHABiotech CO., Ltd

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Responsible Party: CHABiotech CO., Ltd
ClinicalTrials.gov Identifier: NCT02899091     History of Changes
Other Study ID Numbers: CHA-PAD-101
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Keywords provided by CHABiotech CO., Ltd:
Alzheimer's disease
Mesenchymal Stem cells
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders