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Alzheimer's DiseasePhase 1NCT05551741

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

A Phase 1 study testing IBC-Ab002 in people with Alzheimer's Disease, run by Immunobrain Checkpoint at 10 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
IBC-Ab002
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
10 sitesin 3 countries
Study dates
2 Mar 2023to 16 Dec 2025
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of early Alzheimer's disease based on the National Institute on Aging and Alzheimer's Association) (NIA-AA Research Framework criteria, regardless of apolipoprotein E (APOE) gene status.
  • Able to speak, read and write the local language fluently.
  • With respect to symptomatic treatment for Alzheimer's disease, subjects should either be not treated with any approved treatments for AD or stabilized on approved medication(s) other than anti-Ab antibodies for the treatment of AD for at least 3 months prior to Baseline.
  • Subject has a study partner who spends at least 10 hours/week with the subject, and can attend all visits with the subject, report accurately on the subject's status, and ensure compliance with all study requirements
  • Subject and study partner must each independently be able to understand the study requirements and provide informed consent

Who cannot join

  • Females who are not postmenopausal at Screening as defined by amenorrhea for at least 12 consecutive months or who have not been sterilized surgically (i.e. bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before Screening)
  • Other than Alzheimer's disease, any neurologic or medical disorder which may impair cognition.
  • Any contra-indication to undergo magnetic resonance imaging (MRI).
  • Severe vision or hearing impairment that would prevent the subject from performing psychometric tests or otherwise complying with requirements for study participation and activities.
  • History of certain neurological, psychiatric or medical conditions including autoimmune diseases.
  • Clinically significant laboratory or electrocardiogram (ECG) abnormalities
Show all 20Show fewer
  • Presence of contraindication to lumbar puncture (LP) including taking anticoagulant or antiplatelet medications other than aspirin at a dose of ≤ 100 mg/day or clopidogrel.
  • Taking any of the following medications.
  • Immunosuppressant medications, including chronic systemic corticosteroids (chronic use of topical steroids is allowed)
  • Injected or infused antibody therapies, including but not limited to antibodies directed against tumor necrosis factor (TNF), anti-interleukin-6 (anti-IL-6), natalizumab, rituximab and similar agents
  • Aducanumab, (aducanumab-avwa) intravenous injection (brand name: Aduhelm™), or any other experimental or approved anti-amyloid antibody
  • Insulin
  • Anticoagulant or anti-platelet medications including warfarin, heparinoids and direct coagulation factor inhibitors (e.g. apixaban, dabigatran, rivaroxaban) within 90 days of the planned first dose of study drug; either aspirin at a dose of < 100 mg/day or clopidogrel at a dose of 75 mg/day, but not both in combination is permitted
  • Participation in any other interventional clinical trial, or treatment with any investigational drug or investigational use of an approved therapy, within 30 days or 5 half-lives of such agent, whichever is longer, prior to the first Screening visit
  • Subject currently smokes more than 5 cigarettes or equivalent tobacco consumption daily
  • Regular nonmedical use of cannabis or cannabis products unless such products are documented by the manufacturer's label not to contain tetrahydrocannabinol or its derivatives or analogs
  • History of drug (including cannabis) or alcohol abuse within the last 5 years
  • Positive urine drug test for drugs of abuse at Screening. Subjects who test positive for benzodiazepines or opioids in urine drug testing need not be excluded if in the clinical opinion of the investigator, this is due to the subject taking prior/concomitant medications containing benzodiazepines or opioids for a medical condition and not due to drug abuse
  • Subjects who answer "yes" to Columbia Suicidality Rating Scale (C-SSRS) suicidal ideation Type 4 or 5, or any suicidal behavior assessment within 6 months before Screening, at Screening, or has been hospitalized or treated for suicidal behavior in the past 5 years before Screening
  • Unwillingness to comply with study requirements or history of noncompliance in prior clinical trials

Trial locations and contacts

10 sites in 3 countries.

10 sites in 3 countries

United Kingdom5 sites

  • RICE - Research Institute for the Care of Older People

    Bath, BA1 3NG

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

    London, SE5 8AF

  • Dementia Research Centre, National Hospital for Neurology and Neurosurgery

    London

  • Sheffield teaching Hospitals NHS Trust

    Sheffield

  • University Hospital Southampton NHS Foundation Trust

    Southampton, Hampshire

Other trials in United Kingdom

Israel4 sites

  • Barzilai Medical Center

    Ashkelon

  • Rabin Medical Center

    Petah Tikva

  • Sheba Medical Center

    Ramat Gan

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv

Other trials in Israel

Netherlands1 site

  • Brain Research Center

    Amsterdam

Other trials in Netherlands

About this study

Official title: A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IBC-Ab002 in Persons With Early Alzheimer's Disease (AD)

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.

Read the detailed 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.

Being tested
IBC-Ab002, Placebo
Keywords
anti-PD-L1 monoclonal antibody, IBC-Ab002, early Alzheimer's Disease
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IBC-Ab002Biological

    An anti-PD-L1 monoclonal antibody

  • PlaceboOther

    Normal Saline

Study groups in NCT05551741
Study groupRoleWhat they receive
Cohort 1ExperimentalIBC-Ab002 low dose or placebo
Receives: Biological: IBC-Ab002; Other: Placebo
Cohort 2ExperimentalIBC-Ab002 mid low dose or placebo
Receives: Biological: IBC-Ab002; Other: Placebo
Cohort 3ExperimentalIBC-Ab002 mid dose or placebo
Receives: Biological: IBC-Ab002; Other: Placebo
Cohort 4ExperimentalIBC-Ab002 mid high dose or placebo
Receives: Biological: IBC-Ab002; Other: Placebo
Cohort 5ExperimentalIBC-Ab002 high dose or placebo
Receives: Biological: IBC-Ab002; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Subjects With Adverse Events, Serious Adverse Events

    Safety Outcome

    Measured: From first dose (Day 1) through end of follow-up visit (Week 48)

  2. Number of Subjects With Clinically Significant Changes in Hematology Parameters

    Safety Outcome - complete blood count, white blood cells, red blood cells, platelets, hematocrit, mean corpuscular hemoglobin (MCH), neutrophiles percent, neutrophiles absolute, lymphocytes percent, lymphocytes absolute, monocytes percent, monocytes absolute, eosinophils percent, eosinophils absolute, basophils percent, basophils absolute, mean platelet volume.

    Measured: From first dose (Day 1) through end of follow-up visit (Week 48)

  3. Number of Subjects With Clinically Significant Changes in Biochemistry Parameters

    Safety Outcome - sodium, potassium, calcium, phosphorus, glucose, alanine aminotransferase (ALT), aspartate transaminase (AST), lactate dehydrogenase (LDH), creatine kinase (CK), gamma glutamyl transferase (GGT), alkaline phosphatase (ALP), bilirubin, creatine, albumin, total protein, amylase, total cholesterol, triglycerides, thyroid function tests (T3, T4, TSH), coagulation panel International normalized ratio (INR) and partial thromboplastin time (PTT).

    Measured: From first dose (Day 1) through end of follow-up visit (Week 48)

  4. Number of Subjects With Clinically Significant Changes in Urinalysis Parameters

    Safety Outcome - protein, nitrates, glucose, specific gravity, ketones, urobilinogen, bilirubin, pH, hemoglobin.

    Measured: From first dose (Day 1) through end of follow-up visit (Week 48)

  5. Number of Subjects With Clinically Significant Changes in Vital Signs

    Safety outcome - weight, heart rate, respiratory rate, body temperature, systolic and diastolic blood pressure.

    Measured: From first dose (Day 1) through end of follow-up visit (Week 48)

  6. Number of Subjects With Clinically Significant Changes in Physical Examination

    Safety Outcome

    Measured: From first dose (Day 1) through end of follow-up visit (Week 48)

  7. Number of Subjects With Clinically Significant Changes in Electrocardiogram (ECG)

    Safety Outcome

    Measured: From first dose (Day 1) through end of follow-up visit (Week 48)

  8. Number of Subjects With Development of New Abnormalities on Brain MRI

    Safety Outcome - lacunar infarcts, territorial infarct, macroscopic hemorrhage, deep white matter lesions, cerebral contusion, encephalomalacia, infective lesion, aneurysm or vascular malformation, intraparenchymal tumor, meningioma or arachnoid cyst, inflammation, edema.

    Measured: From first dose (Day 1) through end of follow-up visit (Week 48)

  9. Number of Subjects With Increased Suicidality (C-SSRS)

    Safety Outcome - measured using Columbia Suicidality Rating Scale. Part 1 of the scale (Suicidal Ideation) is comprised of 5 yes/no questions with "yes" indicating suicidal ideation and "no" indicating no suicidal ideation.

    Part 2 of the scale (Intensity of Ideation) is comprised of 5 items which should be rated with respect to the most severe type if ideation (with 5 being the most severe intensity and 1 being the least intensity).

    Part 3 of thee scale (Suicidal Behavior) is comprised of 5 yes/no items with "yes" indicating suicidal behavior and "no" indicating no suicidal behavior.

    Part 4 of the scale (Actual Attempts) is comprised of 2 items which should be rated with respect to the most severe outcome of the suicide attempt (with the highest score indicating the most severe outcome and 0 indicating no harm).

    Measured: From first dose (Day 1) through end of follow-up visit (Week 48)

Secondary outcomes (5)

  1. IBC-Ab002 Levels in Serum (PK Parameters: Cmax)

    Pharmacokinetic Outcome - Area under the concentration-time curve from time zero to infinity, area under the concentration-time curve from time zero to the time of the last measurable sample, maximum observed concentration, time to reach maximum observed concentration, terminal elimination half-life, clearance, volume of distribution.

    Measured: Pre-dose and up to Day 84 post-dose

  2. IBC-Ab002 Levels in Serum (PK Parameters: CL)

    Pharmacokinetic Outcome - Area under the concentration-time curve from time zero to infinity, area under the concentration-time curve from time zero to the time of the last measurable sample, maximum observed concentration, time to reach maximum observed concentration, terminal elimination half-life, clearance, volume of distribution.

    Measured: Pre-dose and up to Day 84 post-dose

  3. IBC-Ab002 Levels in Serum (PK Parameters: AUC)

    Pharmacokinetic Outcome - Area under the concentration-time curve from time zero to infinity, area under the concentration-time curve from time zero to the time of the last measurable sample, maximum observed concentration, time to reach maximum observed concentration, terminal elimination half-life, clearance, volume of distribution.

    Measured: Pre-dose and up to Day 84 post-dose

  4. IBC-Ab002 Levels in Serum (PK Parameters: Vd)

    Pharmacokinetic Outcome - Area under the concentration-time curve from time zero to infinity, area under the concentration-time curve from time zero to the time of the last measurable sample, maximum observed concentration, time to reach maximum observed concentration, terminal elimination half-life, clearance, volume of distribution.

    Measured: Pre-dose and up to Day 84 post-dose

  5. Number of Subjects With Positive Serum Anti-IBC-Ab002 Antibodies (ADA)

    Serological Outcome - Number of participants with positive serum anti-IBC-Ab002 antibodies (ADA), summarized by arm.

    Measured: From first dose (Day 1) through end of follow-up visit (Week 48)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2022
  2. Study start2 Mar 2023
  3. Primary completion16 Dec 2025
  4. Study completion16 Dec 2025

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Within each cohort subjects are randomized to either active investigational product or placebo in a ratio 3:1
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05551741
Sponsor's protocol ID
IBC-01-01
Other IDs
1R01AG071810-01, 2021-006580-19, PTCG-20-701033, U1111-1303-6922
Status last verified
Nov 2025
First submitted
14 Jul 2022
Last updated
7 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual study data will be shared with qualified researchers upon review of the request by the trial sponsor

Publications

  • Croese T, Mummery CJ, Bregman N, Bracha D, Baruch K, Kertser A, Raveh S, Shochat E, Schwartz M. Immunotherapy with a short-lived anti-PD-L1 antibody in Alzheimer's disease: a phase 1b, randomized, double-blind trial. Nat Med. 2026 Jul 15. doi: 10.1038/s41591-026-04547-8. Online ahead of print.

    PubMed 42458012

  • Butovsky O, Rosenzweig N. Alzheimer's disease and age-related macular degeneration: Shared and distinct immune mechanisms. Immunity. 2025 May 13;58(5):1120-1139. doi: 10.1016/j.immuni.2025.04.013. Epub 2025 May 4.

    PubMed 40324382

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IBC-Ab002 in people with Alzheimer's Disease, run by Immunobrain Checkpoint at 10 sites in 3 countries.

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 5 inclusion and 20 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: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United Kingdom, Israel, Netherlands. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Subjects With Adverse Events, Serious Adverse Events (time frame: From first dose (Day 1) through end of follow-up visit (Week 48)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05551741, which also lists 2 linked publications.

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 7 Aug 2026.

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