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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02899091
• Other study ID #: CHA-PAD-101
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: September 2016
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: CHABiotech CO., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Bundang Medical Center	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
CHABiotech CO., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes from the baseline in K-MMSE Score	K-MMSE, Korean-Mini Mental Status Examination	48 weeks
Secondary	Change from the baseline of CMRglc analyzed with SPM (statistical parametric mapping) with Brain FDG PET imaging	CMRglc, cerebral metabolic rate for glucose	48 weeks
Secondary	Changes from the baseline of Amyloid amount analyzed with SPM with amyloid PET imaging	SPM, statistical parametric mapping	48 weeks
Secondary	Changes of band power in qEEG	qEEG, Quantitative electroencephalography	48 weeks