CompletedPhase 1

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

Israel, Netherlands, United Kingdom40 participantsStarted 2023-03-02

Plain-language 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.

Who can participate

Age range

50 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Subjects With Adverse Events, Serious Adverse Events

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

Number of Subjects With Clinically Significant Changes in Hematology Parameters

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

Number of Subjects With Clinically Significant Changes in Biochemistry Parameters

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

Number of Subjects With Clinically Significant Changes in Urinalysis Parameters

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

Number of Subjects With Clinically Significant Changes in Vital Signs

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

Number of Subjects With Clinically Significant Changes in Physical Examination

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

Trial details

NCT IDNCT05551741

SponsorImmunobrain Checkpoint

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-16

Results submitted2026-05-18

View on ClinicalTrials.gov More Alzheimer's Disease trials

Plain-language summary

Who can participate

Age range

50 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

What they're measuring

Number of Subjects With Adverse Events, Serious Adverse Events

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

Number of Subjects With Clinically Significant Changes in Hematology Parameters

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

Number of Subjects With Clinically Significant Changes in Biochemistry Parameters