A First in Human Study of IBC-Ab002 in Persons With Early Alzheimer's Disease (AD)

Last updated: April 8, 2025
Sponsor: Immunobrain Checkpoint
Overall Status: Active - Not Recruiting

Phase

1

Condition

Dementia

Alzheimer's Disease

Memory Loss

Treatment

IBC-Ab002

Placebo

Clinical Study ID

NCT05551741
IBC-01-01
PTCG-20-701033
1R01AG071810-01
2021-006580-19
U1111-1303-6922
  • Ages 50-80
  • All Genders

Study Summary

This is a randomized, double-blind, placebo-controlled first-in-human, Phase 1, safety, tolerability, pharmacokinetic (PK) and preliminary exploratory activity study of escalating multiple intravenous (IV) doses of IBC-Ab002 in persons with early Alzheimer's disease. The study will have both Single- and Multiple-Ascending Dose components.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis of early Alzheimer's disease based on the National Institute on Aging andAlzheimer's Association) (NIA-AA Research Framework criteria, regardless ofapolipoprotein E (APOE) gene status.

  2. Able to speak, read and write the local language fluently.

  3. With respect to symptomatic treatment for Alzheimer's disease, subjects shouldeither be not treated with any approved treatments for AD or stabilized on approvedmedication(s) other than anti-Ab antibodies for the treatment of AD for at least 3months prior to Baseline.

  4. Subject has a study partner who spends at least 10 hours/week with the subject, andcan attend all visits with the subject, report accurately on the subject's status,and ensure compliance with all study requirements

  5. Subject and study partner must each independently be able to understand the studyrequirements and provide informed consent

Exclusion

Exclusion Criteria:

  1. Females who are not postmenopausal at Screening as defined by amenorrhea for atleast 12 consecutive months or who have not been sterilized surgically (i.e.bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all withsurgery at least 1 month before Screening)

  2. Other than Alzheimer's disease, any neurologic or medical disorder which may impaircognition.

  3. Any contra-indication to undergo magnetic resonance imaging (MRI).

  4. Severe vision or hearing impairment that would prevent the subject from performingpsychometric tests or otherwise complying with requirements for study participationand activities.

  5. History of certain neurological, psychiatric or medical conditions includingautoimmune diseases.

  6. Clinically significant laboratory or electrocardiogram (ECG) abnormalities

  7. Presence of contraindication to lumbar puncture (LP) including taking anticoagulantor antiplatelet medications other than aspirin at a dose of ≤ 100 mg/day orclopidogrel.

  8. Taking any of the following medications.

  9. Immunosuppressant medications, including chronic systemic corticosteroids (chronic use of topical steroids is allowed)

  10. Injected or infused antibody therapies, including but not limited to antibodiesdirected against tumor necrosis factor (TNF), anti-interleukin-6 (anti-IL-6),natalizumab, rituximab and similar agents

  11. Aducanumab, (aducanumab-avwa) intravenous injection (brand name: Aduhelm™), orany other experimental or approved anti-amyloid antibody

  12. Insulin

  13. Anticoagulant or anti-platelet medications including warfarin, heparinoids anddirect coagulation factor inhibitors (e.g. apixaban, dabigatran, rivaroxaban)within 90 days of the planned first dose of study drug; either aspirin at adose of < 100 mg/day or clopidogrel at a dose of 75 mg/day, but not both incombination is permitted

  14. Participation in any other interventional clinical trial, or treatment with anyinvestigational drug or investigational use of an approved therapy, within 30 daysor 5 half-lives of such agent, whichever is longer, prior to the first Screeningvisit

  15. Subject currently smokes more than 5 cigarettes or equivalent tobacco consumptiondaily

  16. Regular nonmedical use of cannabis or cannabis products unless such products aredocumented by the manufacturer's label not to contain tetrahydrocannabinol or itsderivatives or analogs

  17. History of drug (including cannabis) or alcohol abuse within the last 5 years

  18. Positive urine drug test for drugs of abuse at Screening. Subjects who test positivefor benzodiazepines or opioids in urine drug testing need not be excluded if in theclinical opinion of the investigator, this is due to the subject takingprior/concomitant medications containing benzodiazepines or opioids for a medicalcondition and not due to drug abuse

  19. Subjects who answer "yes" to Columbia Suicidality Rating Scale (C-SSRS) suicidalideation Type 4 or 5, or any suicidal behavior assessment within 6 months beforeScreening, at Screening, or has been hospitalized or treated for suicidal behaviorin the past 5 years before Screening

  20. Unwillingness to comply with study requirements or history of noncompliance in priorclinical trials

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: IBC-Ab002
Phase: 1
Study Start date:
February 23, 2023
Estimated Completion Date:
November 01, 2025

Study Description

Subjects in 5 sequential cohorts of 8 subjects each will be assigned in a 3:1 ratio to receive either IBC-Ab002 or matching placebo 4 times. Part A will be a single-ascending dose study and Part B will be a multiple ascending dose study. The two parts of the study will be intercalated such that subjects will be dosed once every 12 weeks. However, repeated dosing at any dose level will not begin until the anticipated cumulative dose for that cohort has been equaled or exceeded in Part A and/or B of the study, and appropriate safety review of data from all preceding doses in prior subjects has taken place. All subjects randomized into Part A of the study will automatically continue into Part B unless dosing is halted at the individual or group level due to safety or other concerns.

Connect with a study center

  • Barzilai Medical Center

    Ashkelon,
    Israel

    Site Not Available

  • Rambam Health Care Campus

    Haifa,
    Israel

    Site Not Available

  • Rabin Medical Center

    Petach Tikva,
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan,
    Israel

    Site Not Available

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv,
    Israel

    Site Not Available

  • Brain Research Center

    Amsterdam,
    Netherlands

    Site Not Available

  • University Hospital Southampton NHS Foundation Trust

    Southampton, Hampshire
    United Kingdom

    Site Not Available

  • RICE - Research Institute for the Care of Older People

    Bath, BA1 3NG
    United Kingdom

    Site Not Available

  • Dementia Research Centre, National Hospital for Neurology and Neurosurgery

    London,
    United Kingdom

    Site Not Available

  • King's College London - Institute of Psychiatry, Psychology & Neuroscience (IoPPN)

    London, SE5 8AF
    United Kingdom

    Site Not Available

  • Sheffield teaching Hospitals NHS Trust

    London,
    United Kingdom

    Site Not Available

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