Study on the Long-term Safety and Effects of AL002 and Florquinitau F18 in Patients with 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 Alzheimer’s Disease, a condition that affects memory and other important mental functions. The treatment being tested is called AL002, which is a type of medication known as a monoclonal antibody. Monoclonal antibodies are proteins made in a lab that can bind to specific targets in the body, in this case, a protein called TREM2. The study also involves an optional imaging assessment using a substance called florquinitau F18, also known by its code name [18F]MK-6240, which helps in visualizing certain brain changes associated with Alzheimer’s Disease.

The purpose of this study is to evaluate the long-term safety and tolerability of AL002 in people with Alzheimer’s Disease. Participants who have completed a previous study with AL002 are eligible to continue in this extension study. The study will monitor participants over a period to assess how well they tolerate the treatment and to observe any effects on their health. Some participants may also undergo imaging tests to help researchers understand how the treatment affects the brain.

During the study, participants will receive AL002 through an intravenous infusion, which means the medication is given directly into a vein. The study will also include regular health check-ups, including physical exams and tests like MRI scans, to ensure the safety of the participants. The study aims to gather important information that could help improve the understanding and treatment of Alzheimer’s Disease in the future.

1 joining the study

Upon joining the study, the participant must have completed the planned treatment period in the previous AL002-2 study without prematurely discontinuing the study drug.

The participant must agree not to donate blood or blood products for transfusion during the study and for one year after the final dose of the study drug.

2 initial assessments

Initial assessments may include optional imaging assessments such as Tau PET and Amyloid PET imaging, provided the participant has not had excessive radiation exposure prior to enrollment.

The participant must be willing and able to give informed consent, or a legally authorized representative must provide consent on their behalf if necessary.

3 medication administration

The participant will receive a solution for injection of a human monoclonal antibody against TREM2, administered through intravenous infusion.

The study aims to evaluate the long-term safety and tolerability of this medication in participants with Alzheimer’s disease.

4 monitoring and follow-up

Throughout the study, the participant will undergo regular monitoring, including assessments of vital signs, clinical laboratory results, and physical, neurological, ophthalmological examinations, and ECG.

The study will also monitor for any adverse events, including serious adverse events and specific conditions such as ARIA during medication titration.

5 completion of the study

The study is estimated to end on October 28, 2025.

Participants are expected to complete all aspects of the study, including MRI assessments, and must have adequate visual and auditory acuity to perform neuropsychological testing.

Who Can Join the Study?

The participant must have completed the planned treatment period in the previous AL002-2 study without stopping the study drug early.
The participant agrees not to donate blood or blood products during the study and for one year after the last dose of the study drug.
For participants in the optional Tau PET imaging assessment: The participant must not have had too much radiation exposure before joining the trial, according to local standards.
For participants in the optional Tau PET imaging assessment: The imaging center must have access to the [18F]MK-6240 tracer, based on local rules and distribution.
For participants in the optional Amyloid PET imaging assessment: The participant must not have had too much radiation exposure before joining the trial, according to local standards.
For participants in the optional Amyloid PET imaging assessment: The imaging center must have access to an approved amyloid tracer, based on local rules and distribution.
The participant must be willing and able to give informed consent. If the participant cannot provide consent, a legally authorized representative must do so, and the participant must agree, following local rules and guidelines.
Female participants must not be pregnant or breastfeeding. They must either be unable to become pregnant or agree to use birth control from the start of the study until 12 weeks after the last dose. Birth control can include hormonal methods, an intrauterine device, or total abstinence.
Male participants must agree to use birth control and not donate sperm from the start of the study until 12 weeks after the last dose. Birth control for males includes using a condom, and their female partners must also use birth control.
The participant must weigh 120 kg or less and have a body mass index (BMI) between 18.5 and 34.9 kg/m².
The participant must have a “study partner” who has regular contact with them, can provide accurate information about their abilities, and agrees to participate in clinic visits. The study partner must be in good health and able to maintain their role throughout the study.
The participant and study partner must be fluent in the language used for the study tests.
The participant must be willing and able to complete all parts of the study, including MRI scans. They should be able to do assessments alone or with help from the study partner. If the disease progresses, they can still participate for safety assessments.
The participant must have good enough vision and hearing, with or without aids, to complete the neuropsychological tests.

Who Cannot Join the Study?

Participants who do not have a diagnosis of Alzheimer’s Disease cannot join the study. Alzheimer’s Disease is a condition that affects the brain and memory.
Individuals who are not within the specified age range for the study cannot participate. The age range is determined by the study organizers.
Participants who are not part of the specified clinical trial group cannot take part. This group is defined by the study organizers based on certain characteristics.
Both males and females are eligible, so gender is not a reason for exclusion.
Participants who are considered part of a vulnerable population may be excluded. A vulnerable population includes people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Fundacio Ace Institut Catala De Neurociencies Aplicades	Barcelona	Spain
Hospital Universitario Dr Peset Aleixandre	Valencia	Spain
Neuroprotect Sp. z o.o.	Warsaw	Poland
Euromedis Sp. z o.o.	Szczecin	Poland
Brain Research Center Den Bosch B.V.	s-Hertogenbosch	The Netherlands
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Ospedale Fatebenefratelli Isola Tiberina Gemelli Isola	Rome	Italy
Provincia Lombardo Veneta Dell’ordine Ospedaliero Di San Giovanni Di Dio Fatebenefratelli	Brescia	Italy
Azienda Sanitaria Locale Della Provincia Di Biella	Ponderano	Italy
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Hopital Beaujon	Clichy	France
Universita Degli Studi Di Brescia	Brescia	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Azienda Ospedaliero Universitaria Pisana	Pisa	Italy
NZOZ Wrocławskie Centrum Alzheimerowskie	Wroclaw	Poland
Cqocxmr Uvwtbhnyhgstrmyxruz Bjtzum – Crxgda Bixwofjm Fhnqlfhw	Berlin	Germany
Hfgngnwp Dm Lx Swvkl Cwlj I Snog Pqb	Barcelona	Spain
Uwfsegfmfw Dckmw Sqfca Dr Rczs Lt Szhwrlal	Rome	Italy

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.04.2023
Germany	Not recruiting	01.04.2023
Italy	Not recruiting	01.04.2023
Poland	Not recruiting	01.04.2023
Spain	Not recruiting	01.04.2023
The Netherlands	Not recruiting	01.04.2023

Trial locations

Investigated drugs:

AL002 is a medication being studied for its potential use in treating Alzheimer’s disease. The trial aims to assess how safe and well-tolerated AL002 is when used over a long period. Researchers are also looking at how the body’s immune response to AL002 might affect its safety and how it behaves in the body. This study is important for understanding if AL002 can be a viable treatment option for people with Alzheimer’s disease.

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, which gradually worsen over time. As the disease progresses, individuals may experience difficulties with language, disorientation, mood swings, and behavioral changes. Eventually, it can lead to severe memory impairment and loss of the ability to carry out daily activities. The exact cause of Alzheimer’s is not fully understood, but it involves the accumulation of proteins in the brain, such as amyloid plaques and tau tangles. The progression of symptoms varies among individuals, but it generally follows a slow and steady decline.

Trial ID:

2023-506872-29-00

Protocol code:

AL002-LTE

NCT ID:

NCT05744401

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Long-term Safety and Effects of AL002 and Florquinitau F18 in Patients with Alzheimer’s Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?