Phase
Condition
Dementia
Alzheimer's Disease
Memory Loss
Treatment
IBC-Ab002
Placebo
Clinical Study ID
Ages 50-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of early Alzheimer's disease based on the National Institute on Aging andAlzheimer's Association) (NIA-AA Research Framework criteria, regardless ofapolipoprotein E (APOE) gene status.
Able to speak, read and write the local language fluently.
With respect to symptomatic treatment for Alzheimer's disease, subjects shouldeither be not treated with any approved treatments for AD or stabilized on approvedmedication(s) other than anti-Ab antibodies for the treatment of AD for at least 3months prior to Baseline.
Subject has a study partner who spends at least 10 hours/week with the subject, andcan 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 studyrequirements and provide informed consent
Exclusion
Exclusion Criteria:
Females who are not postmenopausal at Screening as defined by amenorrhea for atleast 12 consecutive months or who have not been sterilized surgically (i.e.bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all withsurgery at least 1 month before Screening)
Other than Alzheimer's disease, any neurologic or medical disorder which may impaircognition.
Any contra-indication to undergo magnetic resonance imaging (MRI).
Severe vision or hearing impairment that would prevent the subject from performingpsychometric tests or otherwise complying with requirements for study participationand activities.
History of certain neurological, psychiatric or medical conditions includingautoimmune diseases.
Clinically significant laboratory or electrocardiogram (ECG) abnormalities
Presence of contraindication to lumbar puncture (LP) including taking anticoagulantor antiplatelet medications other than aspirin at a dose of ≤ 100 mg/day orclopidogrel.
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 antibodiesdirected against tumor necrosis factor (TNF), anti-interleukin-6 (anti-IL-6),natalizumab, rituximab and similar agents
Aducanumab, (aducanumab-avwa) intravenous injection (brand name: Aduhelm™), orany other experimental or approved anti-amyloid antibody
Insulin
Anticoagulant or anti-platelet medications including warfarin, heparinoids anddirect coagulation factor inhibitors (e.g. apixaban, dabigatran, rivaroxaban)within 90 days of the planned first dose of study drug; either aspirin at adose of < 100 mg/day or clopidogrel at a dose of 75 mg/day, but not both incombination is permitted
Participation in any other interventional clinical trial, or treatment with anyinvestigational drug or investigational use of an approved therapy, within 30 daysor 5 half-lives of such agent, whichever is longer, prior to the first Screeningvisit
Subject currently smokes more than 5 cigarettes or equivalent tobacco consumptiondaily
Regular nonmedical use of cannabis or cannabis products unless such products aredocumented by the manufacturer's label not to contain tetrahydrocannabinol or itsderivatives 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 positivefor benzodiazepines or opioids in urine drug testing need not be excluded if in theclinical opinion of the investigator, this is due to the subject takingprior/concomitant medications containing benzodiazepines or opioids for a medicalcondition and not due to drug abuse
Subjects who answer "yes" to Columbia Suicidality Rating Scale (C-SSRS) suicidalideation Type 4 or 5, or any suicidal behavior assessment within 6 months beforeScreening, at Screening, or has been hospitalized or treated for suicidal behaviorin the past 5 years before Screening
Unwillingness to comply with study requirements or history of noncompliance in priorclinical trials
Study Design
Study Description
Connect with a study center
Barzilai Medical Center
Ashkelon,
IsraelSite Not Available
Rambam Health Care Campus
Haifa,
IsraelSite Not Available
Rabin Medical Center
Petach Tikva,
IsraelSite Not Available
Sheba Medical Center
Ramat Gan,
IsraelSite Not Available
Tel-Aviv Sourasky Medical Center
Tel Aviv,
IsraelSite Not Available
Brain Research Center
Amsterdam,
NetherlandsSite Not Available
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire
United KingdomSite Not Available
RICE - Research Institute for the Care of Older People
Bath, BA1 3NG
United KingdomSite Not Available
Dementia Research Centre, National Hospital for Neurology and Neurosurgery
London,
United KingdomSite Not Available
King's College London - Institute of Psychiatry, Psychology & Neuroscience (IoPPN)
London, SE5 8AF
United KingdomSite Not Available
Sheffield teaching Hospitals NHS Trust
London,
United KingdomSite Not Available
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