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

NCT02899091 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: CHA-PAD-101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease; Mesenchymal Stem cells

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Changes from the baseline in K-MMSE Score

  48 weeks

• Change from the baseline of CMRglc analyzed with SPM (statistical parametric mapping) with Brain FDG PET imaging

  48 weeks

• Changes from the baseline of Amyloid amount analyzed with SPM with amyloid PET imaging

  48 weeks

• Changes of band power in qEEG

  48 weeks

Study Arms (2)

CB-AC-02

EXPERIMENTAL

Subjects with Alzheimer's disease Intervention: CB-AC-02

Biological: CB-AC-02

Placebo

PLACEBO COMPARATOR

Subjects with Alzheimer's disease Intervention: Placebo

Biological: Placebo

Interventions

CB-AC-02 BIOLOGICAL

Stage1: ① Group1: CB-AC-02 administration on day 0 ② Group2: CB-AC-02 administration on day 0 and on week 4 (repeated injection) Stage2 ① Arm1: K-MMSE 20\~26 CB-AC-02 administration on day 0 and on week 4 (repeated injection) ② Arm2: K-MMSE 10\~19 CB-AC-02 administration on day 0 and on week 4 (repeated injection)

CB-AC-02

Placebo BIOLOGICAL

Stage2: Placebo administration on day 0 and on week 4 (repeated injection)

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Presence of brain atrophy on brain MRI by visual assessment
• Presence of reduced brain glucose metabolism in bilateral temporal-parietal lobe on FDG-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)

You may not qualify if:

• 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
• Use a condom
• Use of contraceptive (oral, dermal, or injectable)
• Use an intra-uterine contraceptive device
• 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

Sponsors & Collaborators

• CHABiotech CO., Ltd: lead

Study Sites (1)

Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Hyun Sook Kim

  CHA University Bundang Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: September 14, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-02

Locations

KR (1)