A PATIENT- AND INVESTIGATOR-BLIND, PLACEBOCONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF BEPRANEMAB (UCB0107) IN STUDY PARTICIPANTS WITH PRODROMAL TO MILD ALZHEIMER’S DISEASE (AD), FOLLOWED BY AN OPENLABEL EXTENSION PERIOD

  • STATUS
    Recruiting
  • sponsor
    UCB Pharma
Updated on 24 June 2022

Summary

Bepranemab (UCB0107) is being developed with the aim of blocking or reducing the cell-to-cell spread of tau pathology in patients with tau-mediated diseases, such as AD. To date, single ascending doses of bepranemab (up to 120mg/kg) have been evaluated in healthy study participants in two Phase 1 studies and no safety concerns were identified

Description

The primary objective is to investigate the effect of bepranemab (45mg/kg and 90mg/kg Q4W) vs placebo on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB), a scale used to quantify the severity of symptoms of dementia, as the change from Baseline to Week 80 in the CDR-SB total score, in study participants with prodromal to mild AD.

Contact: Recruitment Team Member
Phone number: 571-418-0142

Details
Condition PRODROMAL ALZHEIMER’S and MILD ALZHEIMER’S DISEASE
Clinical Study IdentifierTX299668
SponsorUCB Pharma
Last Modified on24 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participant must be 50 to 80 years of age, inclusive, at the time of signing the ICF
Participants who have a diagnosis of prodromal/MCI due to AD-intermediate likelihood or mild AD
Have a global CDR score of 0.5 and CDR-Memory Box (CDR-MB) score ≥0.5 at Screening and Baseline
Participant has a score of ≤85 for the delayed recall domain of the RBANS at Screening
Participant has a MMSE score ≥20 at Screening

Exclusion Criteria

Participant has any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the participant’s AD (eg, folic acid/Vitamin B12 deficiency)
Participant has a history of transient ischemic attacks, stroke, or seizures within 12 months of Screening
Participant has contraindications to PET or MRI scanning, including cardiac pacemaker/defibrillator, ferromagnetic metal implants (example in skull and cardiac devicesother than those approved as safe for use in MRI scanners) or the inability to tolerate brain MRI or PET that would impact collection of a good quality scan
Participant has evidence of other clinically significant lesions on brain MRI at Screening that could indicate a dementia diagnosis other than AD
Participant has had lymphoma, leukemia, or any malignancy within the past 5 years except for: a) Basal cell carcinomas that have been fully resected; or b) Squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years; or c) Breast cancer within the past 10 years
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