Study on the Effectiveness and Safety of GSK4527226 in 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 new treatment for Alzheimer’s Disease, a condition that affects memory and thinking skills. The treatment being tested is called GSK4527226, which is given as an intravenous infusion, meaning it is administered directly into the bloodstream through a vein. The study will compare the effects of this treatment to a placebo in patients who are in the early stages of Alzheimer’s Disease.

The purpose of the study is to evaluate how well GSK4527226 works in improving symptoms of Alzheimer’s Disease. Participants will receive either the new treatment or a placebo and will be monitored over a period of time to assess changes in their condition. The study will involve regular visits to the clinic for assessments and monitoring of health and cognitive abilities.

In addition to GSK4527226, the study will use other substances such as Normal Saline for infusion purposes. The trial will also involve imaging agents like Florquinitau (18F), Florbetaben (18F), Florbetapir (18F), and Flutemetamol (18F), which are used in brain scans to help visualize changes in the brain associated with Alzheimer’s Disease. These agents are administered as solutions for injection. The study aims to provide valuable information on the safety and effectiveness of the new treatment in managing early Alzheimer’s Disease.

1 joining the study

Upon joining the study, the participant will be randomly assigned to one of three groups. This process is double-blind, meaning neither the participant nor the researchers know which group the participant is in.

The groups include two different doses of the medication GSK4527226 and a placebo group.

2 initial assessment

An initial assessment will be conducted to establish a baseline for the participant’s condition. This includes measuring cognitive and functional abilities using various scales such as the Clinical Dementia Rating-Sum of Boxes (CDR-SB).

3 medication administration

Participants will receive an intravenous infusion of the assigned treatment. The medication GSK4527226 or placebo will be administered according to the study schedule.

The frequency and dosage of the medication will be determined by the study protocol and may vary depending on the group assignment.

4 ongoing assessments

Throughout the study, participants will undergo regular assessments to monitor changes in their condition. These assessments will occur at specified intervals, including weeks 52, 64, and 76.

The assessments will measure changes in cognitive and functional abilities using scales such as the CDR-SB, iADRS, and ADAS-Cog14.

5 completion of the study

At the end of the study period, a final assessment will be conducted to evaluate the overall impact of the treatment.

Participants will be informed of their group assignment and the results of the study will be shared with them.

Who Can Join the Study?

Participant must be between 50 and 85 years old.
Participant must be in the early stages of Alzheimer’s, which includes mild cognitive impairment (MCI) or mild Alzheimer’s dementia.
Participant must show signs of cerebral amyloidosis, which means having a buildup of a protein called amyloid in the brain. This can be confirmed by a positive amyloid PET scan or a specific test of the spinal fluid.
Participant must meet certain criteria to determine the severity of their condition:
- MMSE score (a test that measures thinking ability) between 21 and 29 points.
- CDR-GS (a scale that measures dementia severity) between 0.5 and 1.0.
- CDR Memory Box score greater than 0.5.
- WMS-IV LMII score (a memory test) at least 1 standard deviation below the average for their age group:
  - 15 or less for ages 50 to 64 years.
  - 12 or less for ages 65 to 69 years.
  - 11 or less for ages 70 to 74 years.
  - 9 or less for ages 75 to 79 years.
  - 7 or less for ages 80 to 90 years.
If taking medications for Alzheimer’s symptoms, such as donepezil, rivastigmine, galantamine, or memantine, the dosage must have been stable for at least 12 weeks before the study and should not change during the study.
If taking other medications for Alzheimer’s-related symptoms, the dosage must have been stable for at least 4 weeks before the study and should not change during the study.
Participant’s body weight must be between 45 kg and 120 kg, with a BMI (a measure of body fat based on height and weight) between 17 and 34.9.
Female participants must not be pregnant or breastfeeding and must follow specific birth control guidelines.
Male participants must follow specific birth control guidelines.
Participant must be willing and able to give informed consent, which means they agree to follow the study’s rules and requirements.
An adult who knows the participant well must be available to provide information about the participant’s thinking and daily abilities, attend clinic visits, and sign the consent form as a study partner.

Who Cannot Join the Study?

Participants with any other serious health 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 who are currently participating in another clinical trial.
Individuals with a history of drug or alcohol abuse.
Participants who are unable to comply with the study procedures.
Women who are pregnant or breastfeeding.
Individuals with a known allergy to the study medication or its ingredients.
People with severe liver or kidney disease.
Participants with a history of certain mental health disorders.
Individuals who have had a stroke or heart attack in the past six months.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario De Salamanca	Salamanca	Spain
Centre Hospitalier Universitaire De Lille	Lille	France
Oslo Universitetssykehus HF	Oslo	Norway
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario De Navarra	Pamplona	Spain
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Ospedale San Raffaele S.r.l.	Milan	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Fundacio Assistencial De Mutua De Terrassa Fpc	Terrassa	Spain
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino	Pavia	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Santa Maria Della Misericordia	Perugia	Italy
Helse Stavanger HF	Stavanger	Norway
University Of Eastern Finland	Kuopio	Finland
Clinical Research Services Turku CRST Oy	Turku	Finland
Fundacio Ace Institut Catala De Neurociencies Aplicades	Barcelona	Spain
CRST Helsinki Oy	Helsinki	Finland
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Brain Research Center Amsterdam B.V.	Amsterdam	The Netherlands
Brain Research Center Zwolle B.V.	Zwolle	The Netherlands
Fondazione Istituto G. Giglio Di Cafalu	Cefalu'	Italy
Brain Research Center Den Bosch B.V.	s-Hertogenbosch	The Netherlands
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Universita Degli Studi Di Brescia	Brescia	Italy
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Karolinska University Hospital	Solna	Sweden
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Neuro Centrum Science GmbH	Erbach	Germany
Hwifirygclsc Dycssncum Svppynk Ab	Bergen	Norway
Urdmidfwlt Hamisfcze Pmkjf Snptcyehknv Cjslvfz Fske	Paris	France
Fgpcxnhwp Ptkd Lp Ixaekhwzuitvz Bgyyvhzwe Ddw Hoaxmanw Urrsitbrfguhu Lm Pan	Madrid	Spain
Uamuvfsfjhuvtvxgbsjiq Maboxzqu Avg	Munster	Germany
Kbxopguh doy Uxtmbdeqqpuu Mkzyoqic Acm	Munich	Germany
Savuvq Ttyxbgiimdn Oa	Turku	Finland
Hddmcttt Unghhmunimzvrh Sdcdaezgta &acfzer Htdyisz dw Hjvlcjgmpov	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Finland	Not recruiting	19.12.2023
France	Not recruiting	19.12.2023
Germany	Not recruiting	19.12.2023
Italy	Not recruiting	19.12.2023
Norway	Not recruiting	19.12.2023
Spain	Not recruiting	19.12.2023
Sweden	Not recruiting	19.12.2023
The Netherlands	Not recruiting	19.12.2023

Trial locations

Investigated drugs:

GSK4527226 [AL101] is an investigational medication being studied for its potential to treat early Alzheimer’s disease. It is administered through an intravenous infusion. The goal of this medication in the trial is to assess its effectiveness in improving symptoms of Alzheimer’s disease, specifically by measuring changes in the Clinical Dementia Rating – Sum of Boxes (CDR-SB), which is a tool used to evaluate the severity of dementia symptoms.

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. 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 a combination of genetic, environmental, and lifestyle factors. The progression of the disease varies from person to person, but it generally follows a slow and steady decline in cognitive and functional abilities.

Trial ID:

2023-505083-11-01

Protocol code:

219867

NCT ID:

NCT06079190

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness and Safety of GSK4527226 in Patients with Early Alzheimer’s Disease

What is this study about?

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