Alzheimer's DiseasePhase 1/2NCT02899091
Evaluation of the Safety and Potential Therapeutic Effects of CB-AC-02 in Patients With Alzheimer's Disease
A Phase 1/2 study testing CB-AC-02 in people with Alzheimer's Disease, run by CHABiotech CO., Ltd at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- CB-AC-02
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2016to Dec 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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 )
Show all 16Show fewer
- 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
- Subjects whom the principal investigator considers inappropriate for participation in theis study
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Alzheimer's Disease
- Being tested
- CB-AC-02, Placebo
- Keywords
- Alzheimer's disease, Mesenchymal Stem cells
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CB-AC-02Biological
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)
PlaceboBiological
Stage2:
Placebo administration on day 0 and on week 4 (repeated injection)
| Study group | Role | What they receive |
|---|---|---|
| CB-AC-02 | Experimental | Subjects with Alzheimer's disease Intervention: CB-AC-02 Receives: Biological: CB-AC-02 |
| Placebo | Placebo comparator | Subjects with Alzheimer's disease Intervention: Placebo Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 weeks
Secondary outcomes (4)
Changes from the baseline in K-MMSE Score
K-MMSE, Korean-Mini Mental Status Examination
Measured: 48 weeks
Change from the baseline of CMRglc analyzed with SPM (statistical parametric mapping) with Brain FDG PET imaging
CMRglc, cerebral metabolic rate for glucose
Measured: 48 weeks
Changes from the baseline of Amyloid amount analyzed with SPM with amyloid PET imaging
SPM, statistical parametric mapping
Measured: 48 weeks
Changes of band power in qEEG
qEEG, Quantitative electroencephalography
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHABiotech CO., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyun Sook Kim, Principal investigator, CHA University Bundang Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899091
- Sponsor's protocol ID
- CHA-PAD-101
- Status last verified
- Feb 2024
- First submitted
- 2 Sep 2016
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02899091
- Acronym / sponsor ID
- CHA-PAD-101
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, Mesenchymal Stem cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- CHABiotech CO., LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CB-AC-02 | Experimental | Biological: CB-AC-02Subjects with Alzheimer's disease Intervention: CB-AC-02 |
| Placebo | Placebo comparator | Biological: PlaceboSubjects with Alzheimer's disease Intervention: Placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CB-AC-02Stage1: 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) | Biological | CB-AC-02 |
| PlaceboStage2: Placebo administration on day 0 and on week 4 (repeated injection) | Biological | Placebo |
Primary outcome
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.
4 secondary outcomes
Changes from the baseline in K-MMSE Score
Time frame: 48 weeks
Change from the baseline of CMRglc analyzed with SPM (statistical parametric mapping) with Brain FDG PET imaging
Time frame: 48 weeks
Changes from the baseline of Amyloid amount analyzed with SPM with amyloid PET imaging
Time frame: 48 weeks
Changes of band power in qEEG
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
Related trials for Alzheimer's Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyun Sook Kim principal investigator
CHA University Bundang Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CB-AC-02 in people with Alzheimer's Disease, run by CHABiotech CO., Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.