Study on Bepranemab for Patients with Early Alzheimer’s Disease

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for people with early stages of Alzheimer’s Disease. The treatment being tested is called Bepranemab (also known by its code name UCB0107), which is given as a solution through an infusion into the vein. The study also involves a comparison with a placebo, which is a substance that looks like the treatment but does not contain any active ingredients. Additionally, the study uses a special imaging technique with substances like (18F) GTP1 and Neuraceq to help visualize changes in the brain.

The purpose of the study is to evaluate how effective and safe Bepranemab is for people with early Alzheimer’s Disease. Participants will receive either Bepranemab or a placebo and will be monitored over a period of time to see how their condition changes. The study will also include an open-label extension period, where all participants may receive Bepranemab. During the study, participants will undergo various assessments to track their cognitive abilities and overall health.

Throughout the study, researchers will use different methods to measure changes in the participants’ condition, including the use of imaging techniques to observe the brain. The study aims to provide valuable information on the potential benefits and safety of Bepranemab for treating early Alzheimer’s Disease.

1 joining the study

Upon joining the study, the participant will be assessed to confirm eligibility based on specific criteria related to age, cognitive impairment, and other factors.

The participant must have a diagnosis of early-stage Alzheimer’s Disease and meet other health and cognitive criteria.

2 initial assessment

An initial assessment will be conducted to establish a baseline for cognitive and functional abilities.

This includes tests like the Clinical Dementia Rating and the Mini-Mental State Examination.

3 treatment phase

The participant will receive either bepranemab or a placebo through intravenous infusion.

The treatment will be administered regularly over a period of 80 weeks.

4 monitoring and assessments

Throughout the study, the participant will undergo regular assessments to monitor cognitive function and overall health.

These assessments will include various cognitive tests and brain imaging techniques.

5 safety evaluations

The participant will be monitored for any adverse effects related to the treatment.

Safety evaluations will be conducted to ensure the participant’s well-being.

6 end of treatment phase

At the end of the 80-week treatment phase, a final assessment will be conducted to evaluate changes in cognitive and functional abilities.

The participant’s response to the treatment will be analyzed.

7 open-label extension

Following the double-blind treatment phase, participants may enter an open-label extension period.

During this period, all participants will receive bepranemab to further assess its long-term effects.

Who Can Join the Study?

Age between 50 to 80 years old.
Diagnosis of prodromal or mild cognitive impairment (MCI) due to Alzheimer’s Disease (AD) or mild AD. Prodromal means early signs or symptoms of a disease.
A global Clinical Dementia Rating (CDR) score between 0.5 to 1.0 and a CDR-Memory Box (CDRMB) score of at least 0.5 at the start of the study. These scores help measure the severity of dementia.
Score of 85 or less in the delayed recall part of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) at the start. This test checks memory and thinking skills.
Mini-Mental State Examination (MMSE) score of 20 or higher at the start. This is a test that measures cognitive function.
Must have an informant who knows the participant well and can spend at least 5 hours per week with them. This person will provide information about the participant’s mental, emotional, and daily living abilities.
At least 6 years of formal education after age 5 or work experience to rule out other mental issues besides Alzheimer’s.
Evidence of cerebral Aβ accumulation, which means a build-up of a protein in the brain, shown by a positive amyloid assessment through a positron emission tomography (PET) scan or a specific cerebrospinal fluid test.

Who Cannot Join the Study?

Participants with any other serious medical condition that could interfere with the study.
Individuals who have had a recent major surgery or are planning to have one during the study period.
People with a history of drug or alcohol abuse within the past year.
Participants who are currently taking medications that might affect the study results.
Individuals with a known allergy to the study medication or its ingredients.
People who are pregnant or breastfeeding.
Participants who have been involved in another clinical trial within the last 30 days.
Individuals with a history of severe mental health disorders.
People who are unable to comply with the study procedures or follow-up visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Oncopole Claudius Regaud	Toulouse	France
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Universitario De Navarra	Pamplona	Spain
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Hospital Universitari General De Catalunya	Sant Cugat Del Valles	Spain
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Fondazione Istituto Neurologico Nazionale Casimiro Mondino	Pavia	Italy
Algemeen Ziekenhuis Groeninge	Kortrijk	Belgium
Fundacio Ace Institut Catala De Neurociencies Aplicades	Barcelona	Spain
Hospital Universitario Dr Peset Aleixandre	Valencia	Spain
Insula Centrum Badan Klinicznych Sp. z o.o.	Warsaw	Poland
Fondazione Santa Lucia	Rome	Italy
Revit Sp. z o.o.	Bialystok	Poland
Promente Sp. z o.o.	Bydgoszcz	Poland
Euromedis Sp. z o.o.	Szczecin	Poland
Neuroprotect Sp. z o.o.	Warsaw	Poland
Etg Neuroscience Sp. z o.o.	Warsaw	Poland
Brain Research Center Den Bosch B.V.	s-Hertogenbosch	The Netherlands
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hospital Ruber Juan Bravo	Madrid	Spain
Centre Hospitalier Universitaire De Rennes	Rennes	France
Ospedale Fatebenefratelli Isola Tiberina Gemelli Isola	Rome	Italy
Centre Hospitalier Lyon Sud	Pierre Benite	France
Vrije Universiteit Brussel	Jette	Belgium
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
NZOZ Wrocławskie Centrum Alzheimerowskie	Wroclaw	Poland
Avlydod Oyvpnbybqyr Ubghalnpjuvzi Phumv	Parma	Italy
Uqumauwmqu Hybrktrkt Pwiyz Shaeqydronx Cdecljh Fegk	Paris	France
Ooabwtm Bdzsmzcc Nzrgkva Dyodfnotfke Cyansm Omzpsjwwuxk Ieq Kyceiza Hpfhchb Kssiczpup Gljsbylvlkqo Ohbqmau Adfhexvrkfzxyo Sza z oirv	Scinawa	Poland
Nzovqgzkxelk Zievvg Oqnzmh Zemdmkvmtj Wilzdlevdtbqwjzkbzkp Pgvebwyu Lbcijqrm Swkefgeo Ltqa Sgqthrstfnio	Katowice	Poland
Amhkrasrnj Plzsgboa Hejmgspf Da Mjypwhtjn	Marseille	France
Hdthazgr Dm Lu Srfzo Chgm I Sasx Pfg	Barcelona	Spain
Hendfeki Vszq dgzgzbaf	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	18.10.2021
France	Not recruiting	18.10.2021
Germany	Not recruiting	18.10.2021
Italy	Not recruiting	18.10.2021
Poland	Not recruiting	18.10.2021
Spain	Not recruiting	18.10.2021
The Netherlands	Not recruiting	18.10.2021

Trial locations

Investigated drugs:

Bepranemab (UCB0107) is a medication being studied for its potential to help people with early stages of Alzheimer’s Disease. The trial aims to see if Bepranemab can improve symptoms related to memory and thinking abilities. Participants will receive this medication to evaluate its effectiveness and safety over a period of time.

Alzheimer’s Disease – Alzheimer’s Disease is a progressive neurological disorder that leads to the degeneration of brain cells, causing memory loss and cognitive decline. It typically begins with mild memory lapses and confusion, gradually worsening over time. As the disease progresses, individuals may experience difficulties with language, disorientation, mood swings, and behavioral changes. In advanced stages, individuals may lose the ability to carry out daily activities and require full-time care. The exact cause of Alzheimer’s is not fully understood, but it involves the accumulation of proteins in the brain, leading to cell damage. The progression of symptoms varies among individuals, but it generally follows a slow and steady decline.

Trial ID:

2023-506170-12-00

Protocol code:

AH0003

NCT ID:

NCT04867616

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Bepranemab for Patients with Early Alzheimer’s Disease

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