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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG071810-01 | U.S. NIH Grant/Contract | View source | |
| 2021-006580-19 | EudraCT Number | ||
| PTCG-20-701033 | Other Grant/Funding Number | Alzheimer's Association | |
| U1111-1303-6922 | Other Identifier | Universal Trial Number |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Alzheimer's Association | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | IBC-Ab002 low dose or placebo |
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| Cohort 2 | Experimental | IBC-Ab002 mid low dose or placebo |
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| Cohort 3 | Experimental | IBC-Ab002 mid dose or placebo |
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| Cohort 4 | Experimental | IBC-Ab002 mid high dose or placebo |
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| Cohort 5 | Experimental | IBC-Ab002 high dose or placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBC-Ab002 | Biological | An anti-PD-L1 monoclonal antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of subjects with adverse events, serious adverse events | Safety Outcome | 48 weeks |
| Incidence 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 | 48 weeks |
| Incidence 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). | 48 weeks |
| Incidence of subjects with clinically significant changes in urinalysis parameters | Safety Outcome - protein, nitrates, glucose, specific gravity, ketones, urobilinogen, bilirubin, pH, hemoglobin | 48 weeks |
| Incidence of subjects with clinically significant changes in vital signs | Safety outcome - weight, heart rate, respiratory rate, body temperature, systolic and diastolic blood pressure | 48 weeks |
| Incidence of subjects with clinically significant changes in physical examination |
| Measure | Description | Time Frame |
|---|---|---|
| IBC-Ab002 levels in serum. | 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, | Pre-dose and up to Day 84 post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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
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.
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
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| Name | Affiliation | Role |
|---|---|---|
| Tommaso Croese, MD | Immunobrain Checkpoint | Study Director |
| Catherine Mummery, MD | Dementia Research Centre, UCL, London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barzilai Medical Center | Ashkelon | Israel | ||||
| Rabin Medical Center |
Individual study data will be shared with qualified researchers upon review of the request by the trial sponsor
After the end of the study, submission of the clinical study report and publication of the study results
Upon review of the qualifications of the requesting researcher and the purpose of the research
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 18, 2026 | |
| Reset | Jun 11, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 18, 2026 | Jun 11, 2026 | |||
| Jun 16, 2026 |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Within each cohort subjects are randomized to either active investigational product or placebo in a ratio 3:1
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| Placebo | Other | Normal Saline |
|
Safety Outcome |
| 48 weeks |
| Incidence of subjects with clinically significant changes in electrocardiogram (EEG) | Safety Outcome | 48 weeks |
| Incidence 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 | 48 weeks |
| Incidence of subjects with increased suicidality | 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). | 48 weeks |
| Number of subjects with positive serum anti-IBC-Ab002 antibodies | Pharmacokinetic Outcome | 48 weeks |
| Petah Tikva |
| Israel |
| Sheba Medical Center | Ramat Gan | Israel |
| Tel-Aviv Sourasky Medical Center | Tel Aviv | Israel |
| Brain Research Center | Amsterdam | Netherlands |
| University Hospital Southampton NHS Foundation Trust | Southampton | Hampshire | United Kingdom |
| RICE - Research Institute for the Care of Older People | Bath | BA1 3NG | United Kingdom |
| King's College London - Institute of Psychiatry, Psychology & Neuroscience (IoPPN) | London | SE5 8AF | United Kingdom |
| Dementia Research Centre, National Hospital for Neurology and Neurosurgery | London | United Kingdom |
| Sheffield teaching Hospitals NHS Trust | London | United Kingdom |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |