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CompletedPhase 1

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

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

Asset

IBC-Ab002

Listed sites

10

Recruiting sites

-

Enrollment

40

actual

Study population

Alzheimer’s disease

Key I/E criteria

Alzheimer's diseaseStudy partner/caregiver required

Primary endpoints

Subjects with adverse events, serious adverse eventsSubjects with clinically significant changes in hematology parametersSubjects with clinically significant changes in biochemistry parameters

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Nih1R01AG071810-01
Eudract number2021-006580-19
Org study IDIBC-01-01
NCT IDNCT05551741
Other grantPTCG-20-701033Alzheimer's Association
Secondary IDU1111-1303-6922Universal Trial Number

Timeline

Milestones

Study first posted2022-09-23actual
Study start2023-02-23actual
Primary completion2025-12-16actual
Study completion2025-12-16actual
Last update posted2025-12-24actual

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. 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.

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

3. 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.

4. 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

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

Exclusion criteria

1. 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)

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

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

4. Severe vision or hearing impairment that would prevent the subject from performing psychometric tests or otherwise complying with requirements for study participation and activities.

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

6. Clinically significant laboratory or electrocardiogram (ECG) abnormalities

7. 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.

8. Taking any of the following medications.

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

2. 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

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

4. Insulin

5. 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

9. 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

10. Subject currently smokes more than 5 cigarettes or equivalent tobacco consumption daily

11. 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

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

13. 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

14. 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

15. Unwillingness to comply with study requirements or history of noncompliance in prior clinical trials

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
8
Behavior / neuropsychiatric
1
Neuroimaging
1
Fluid / digital biomarkers
1

Behavior / neuropsychiatric

1 endpoint
Primary/protocol endpoint

Incidence of subjects with increased suicidality

Time frame:48 weeks

event count, event

Neuroimaging

1 endpoint
Primary/protocol endpoint

Incidence of subjects with development of new abnormalities on brain MRI

Time frame:48 weeks

event count, event

Fluid / digital biomarkers

1 endpoint
Primary/protocol endpoint

Incidence of subjects with clinically significant changes in electrocardiogram (EEG)

Time frame:48 weeks

event count, event

Safety / tolerability / PK

8 endpoints
Primary/protocol endpoint

Incidence of subjects with adverse events, serious adverse events

Time frame:48 weeks

event count, event

Primary/protocol endpoint

Incidence of subjects with clinically significant changes in hematology parameters

Time frame:48 weeks

event count, event

Primary/protocol endpoint

Incidence of subjects with clinically significant changes in biochemistry parameters

Time frame:48 weeks

event count, event

Primary/protocol endpoint

Incidence of subjects with clinically significant changes in urinalysis parameters

Time frame:48 weeks

event count, event

Primary/protocol endpoint

Incidence of subjects with clinically significant changes in vital signs

Time frame:48 weeks

event count, event

Primary/protocol endpoint

Incidence of subjects with clinically significant changes in physical examination

Time frame:48 weeks

event count, event

Secondary/protocol endpoint

IBC-Ab002 levels in serum.

Time frame:Pre-dose and up to Day 84 post-dose

time to event, event

Secondary/protocol endpoint

Number of subjects with positive serum anti-IBC-Ab002 antibodies

Time frame:48 weeks

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.