Study on the Safety and Effects of ABBV-916 and MK-6240 for Patients with Early Alzheimer’s Disease

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What is this study about?

This clinical trial is focused on studying Alzheimer’s disease, a condition that affects memory and thinking skills. The study will evaluate a treatment called ABBV-916, which is a special type of protein known as a monoclonal antibody. This protein is designed to target and reduce certain harmful substances in the brain associated with Alzheimer’s disease. The trial will also involve a comparison with a placebo, which is a substance with no active medication, to see how effective the treatment is.

The purpose of the study is to assess the safety and effectiveness of ABBV-916 in people with early stages of Alzheimer’s disease. Participants will receive the treatment through an injection into a vein, known as an intravenous injection. The study will monitor how the treatment affects the brain over time, particularly looking at changes in brain substances linked to Alzheimer’s disease. Another medication, MK-6240, will be used to help measure these changes in the brain.

Throughout the study, participants will have regular check-ups and brain scans to track their progress. The study aims to provide valuable information on whether ABBV-916 can help reduce the harmful substances in the brain and improve symptoms in people with early Alzheimer’s disease. This research is important for developing new treatments that could potentially slow down or improve the condition.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose, procedures, and potential risks and benefits. You will be asked to provide consent to participate.

You will undergo initial assessments to confirm eligibility, including tests to evaluate your memory and thinking abilities, as well as imaging tests to check for specific brain changes associated with Alzheimer’s disease.

2 initial treatment phase

If eligible, you will be randomly assigned to receive either the study medication ABBV-916 or a placebo. A placebo is a substance with no active medication, used for comparison.

The medication will be administered as a solution for injection through a vein, known as an intravenous injection. The frequency and dosage will be determined by the study protocol.

3 ongoing treatment and monitoring

You will receive repeated intravenous administrations of the study medication over a specified period. The primary goal is to evaluate the safety and effects of the medication on brain changes related to Alzheimer’s disease.

Regular visits will be scheduled to monitor your health, assess the medication’s effects, and perform necessary tests, including brain scans and cognitive assessments.

4 evaluation of treatment effects

At week 24, a key assessment will be conducted to measure changes in brain amyloid plaque deposition using a specialized imaging test called an amyloid PET scan.

This evaluation will help determine the effectiveness of the study medication in reducing amyloid plaques, which are associated with Alzheimer’s disease.

5 completion of the study

Upon completing the study, you will undergo final assessments to evaluate your overall health and any changes in your condition.

You will receive information about the study’s findings and any potential next steps regarding your treatment and care.

Who Can Join the Study?

Adult male or female, aged between 50 and 90 years old.
Must have, in the investigator’s opinion, adequate ability to read and write, and good enough vision or hearing to complete the required tests.
Must have a score between 20 and 28 on the MMSE test at the start of the study. The MMSE is a test that checks memory and thinking skills.
Must have a blood test result that suggests the presence of amyloid, a protein linked to Alzheimer’s disease.
Must have a brain scan result that shows amyloid buildup, with a specific measurement called a centiloid value of 37 or higher. This is determined by a visual assessment of the scan.

Who Cannot Join the Study?

Patients who do not have a diagnosis of Alzheimer’s disease cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Salamanca	Salamanca	Spain
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Fundacio Ace Institut Catala De Neurociencies Aplicades	Barcelona	Spain
Hospital Universitari General De Catalunya	Sant Cugat Del Valles	Spain
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
CCAB Centro Clinico Academico Braga Associacao	Braga	Portugal
Policlinica Gipuzkoa S.A.	Donostia / San Sebastian	Spain
Hospital Victoria Eugenia De La Cruz Roja Espanola	Sevilla	Spain
Unidade Local De Saude De Matosinhos E.P.E.	Senhora Da Hora	Portugal
Unidade Local De Saude Do Alto Ave E.P.E.	Guimaraes	Portugal
CNS Saude Lda.	Torres Vedras	Portugal
Oroitu S.L.	Algorta	Spain
Chnooq Hjgsbktewq E Uujtlfssnonox Dq Coqrgnf Eoxeas	Coimbra	Portugal
Idgpfehhn Do Raiburgv E Cljd A Cldrsbtlh Smlfqdluqpt	Brescia	Italy
Ocrtiesu Inkee Tnjctcmf Guodecp Iuagf	Rome	Italy
Ukpeuchoqg Dcgyt Snrik Dk Raac Lr Scebimvs	Rome	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	01.06.2023
Portugal	Not recruiting	01.06.2023
Spain	Not recruiting	01.06.2023

Trial locations

Investigated drugs:

ABBV-916 is a medication being studied for its potential to help people with early Alzheimer’s disease. Alzheimer’s disease is a condition that affects the brain and can lead to memory loss and other cognitive problems. ABBV-916 is given through an intravenous infusion, which means it is administered directly into the bloodstream through a vein. The main goal of using ABBV-916 in this study is to see if it can safely reduce the amount of amyloid in the brain. Amyloid is a protein that can build up in the brains of people with Alzheimer’s disease and is thought to play a role in the development of the condition. By reducing amyloid levels, ABBV-916 may help slow down the progression of Alzheimer’s disease and improve symptoms.

Investigated diseases:

Early onset familial Alzheimer's disease

Alzheimer’s disease – Alzheimer’s disease is a progressive neurological disorder that affects the brain, leading to memory loss and cognitive decline. It typically begins with mild memory lapses and confusion, which gradually worsen 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 disease is characterized by the accumulation of amyloid plaques and tau tangles in the brain, which disrupt communication between nerve cells. This disruption leads to the death of brain cells and a decline in brain function.

Trial ID:

2022-500691-59-00

Protocol code:

M22-721

NCT ID:

NCT05291234

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effects of ABBV-916 and MK-6240 for Patients with Early Alzheimer’s Disease

What is this study about?

Who Can Join the Study?

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