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

CHABiotech CO., Ltd1 site in 1 country24 target enrollmentSeptember 2016

ConditionsAlzheimer's Disease

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Alzheimer's Disease
Sponsor: CHABiotech CO., Ltd
Enrollment: 24
Locations: 1
Primary Endpoint: Number of Adverse Events
Status: Active, Not Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Detailed 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

Registry

clinicaltrials.gov

Start Date

September 2016

End Date

December 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

CHABiotech CO., Ltd

Responsible Party

Sponsor

Eligibility Criteria

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
•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)

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
•Use a condom

Outcomes

Primary Outcomes

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 Outcomes

Change from the baseline of CMRglc analyzed with SPM (statistical parametric mapping) with Brain FDG PET imaging(48 weeks)
Changes from the baseline in K-MMSE Score(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)