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

Recruiting

• Conditions: Alzheimer disease; dementia; 10012272

• Registration Number: NL-OMON56092
• Lead Sponsor: ImmunoBrain Checkpoint, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

1. Age range: 50-80 years of age at the Screening visit
2. Diagnosis of early AD based on the NIA-AA Research Framework criteria,
regardless of APOE gene status
a. Biomarker classification A+T+N+ or A+T+N- based upon Screening CSF profile
consistent with AD defined by either of the following criteria:
i. CSF Aβ42 < 1000 pg/mL and pTau181 > 19 pg/mL
ii. CSF pTau181/Aβ42 ratio > 0.020
b. AD Clinical Stage 3 or 4 based on the National Institute on Aging and
Alzheimer's Association (NIA-AA) Research Framework criteria
i. Gradual and progressive change in memory function reported by the
participant or informant for >=6 months
ii. Have a Mini-Mental State Examination (MMSE) score at Screening between
20-28 inclusive
iii. Clinical Dementia Rating Scale (CDR) global score at Screening of 0.5 or 1
with memory box score >= 0.5
3. Able to speak, read and write the local language fluently
4. With respect to symptomatic treatment for Alzheimer*s disease, subjects
should either be:
a. Not treated with any approved treatments for AD with a reasonable
expectation that, based on the course of illness, need for treatment is not
imminent and the patient should not be initiated on treatment for the length of
the study, OR
b. Stabilized on an approved medication(s) other than anti-Ab antibodies for
the treatment of AD for at least 3 months prior to Baseline. The dose of the AD
treatment should remain the same after entering the study
5. Subject has a study partner who spends at least 10 hours/week with the
patient, and can attend all visits with the patient, report accurately on the
subject*s status and ensure compliance with all study requirements

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. Males who are fertile but refuse to practice double-barrier methods of
contraception with female partners of childbearing potential
3. Other than AD, neurologic or medical disorder which may impair cognition
including: head trauma, seizure disorder, neurodegenerative disease,
hydrocephalus, cerebral / spinal hematoma, inflammatory disease, CNS infection
(e.g. encephalitis or meningitis), neoplasm, toxic exposure, metabolic disorder
(including hypoxic or hypoglycemic episodes), or endocrine disorder, or any
significant medical conditions that, in the opinion of the Investigator, would
prohibit their participation in the study
4. As assessed by the central MRI reader,
a. Magnetic Resonance Imaging (MRI) evidence of a) more than three lacunar
infarcts, b) territorial infarct or macroscopic hemorrhage, or c) deep white
matter lesions corresponding to a Fazekas score = 3
b. Presence of any structural lesion that could potentially explain the
subject*s cognitive impairment, or place the subject at risk for AEs during the
trial. Examples include but are not limited to: cerebral contusion,
encephalomalacia, aneurysm or vascular malformation, infective lesion,
intraparenchymal tumor, meningioma or arachnoid cyst larger than 1 cm in
longest diameter
c. More than 5 Amyloid-Related Imaging Abnormalities-Hemorrhages (ARIA-H)
(including microbleeds and areas of leptomeningeal hemosiderosis (LH)) or more
than 3 areas of LH
5. Any contra-indication to undergo MRI, as judged by local PI or radiologist,
including but not limited to presence of pacemaker, aneurysm clips, artificial
heart valves, ear implants, ventriculoperitoneal shunt, foreign metal objects
in the eyes, skin or body or any other circumstance which would contraindicate
an MRI scan or impair MRI image quality, or history of claustrophobia or of not
tolerating MRI scanning procedures

Study & Design

• Study Type: Interventional
• Study Design: Not specified