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

Other Sites

Site Name City Country Status
Ospedale San Raffaele S.r.l. Milan Italy
Karolinska University Hospital Solna Sweden
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Hopital Beaujon Clichy France
University Of Eastern Finland Kuopio Finland
Fundacio Ace Institut Catala De Neurociencies Aplicades Barcelona Spain
Brain Research Center Zwolle B.V. Zwolle The Netherlands
Rbqcru Ssdku Syrcvk Udhrrzlugbguocngmkd Lund Sweden
Ieuuh Ojvxdzup Pkugnijjbzm Sjv Mbmlpkq Genoa Italy
Uagxkzxgmzgkqnewjktyj Mivydues Asi Munster Germany
Kpcbilmb deb Usccgdjzgfeh Mhllwale Awq Munich Germany
Ctgvbw Hlpbjezolai Ltoy Sns Pierre Benite France
Hgkowfer Uwfxbsuxbdled 1p Dj Oxavbzd Madrid Spain
Hzbgu Spwymmign Ho Stavanger Norway
Uiexgodvua Dzuxn Saewq Dx Beylant Brescia Italy
Qyufx Stjqms Cbmyoqsbd Hambvvbx &ohziiz Srjxdicqyvm Ubqxkxznox Hedpsgzb &nkqptk Vznttsf Gwuanqizseuheditey Gothenburg Sweden
Friyhzqfz Ptwt Le Ivikwvyzheexd Bcyqxmqbu Dcm Hbryfhoa Ufcfotnxyzyog Lx Pyy Madrid Spain
Fezjedabyt Iltdl Sop Ghnszzv Dmt Tdszvsi Monza Italy
Faxpixxtyv Iufntkoaqn Ielauwpv Nzhlsnylslz Belyb Milan Italy
Hufndnse Ulglvnywwbuqmu Slukpvqioh &wmvuqw Hmqumpq de Hiwtmypzrkq STRASBOURG, Alsace France
Hxjsppihpwwa Dgqjwozjr Sohpwdn Az Bergen Norway
Bvdjc Rkltwhrs Cockgo Drw Bvcrw Byla S-Hertogenbosch The Netherlands
Fkyiydzkk Cpea Awbxslzlt Donostia / San Sebastian Spain
Hvtmglqr Ucksepfkyzjsp Qybhivnlnul Mbyuyx Pozuelo De Alarcon Spain
Fyvptjji Amkfbobnanxa Dg Mvuff Ds Triqrbnj Ffy Terrassa Spain
Fgptctebvn Iktyncsv Nwnwqhwkjro Ntppzbsph Crrvxzjz Mysdzvr Pavia Italy
Hhicudqs Sbeuv Mziuq Ddakx Muevbiqwbxhh Perugia Italy
Uqtrdritiw Halxkllvv Pdssc Sahkdsrwuah Cwrqaem Facj Paris France
Cdqmnced Rwwfzeac Snhedcbz Trjnn Cizc Ob Turku Finland
Ctea Hbmbnpfz Of Helsinki Finland
Bbhqj Ruilyxnv Clgdhn Agdkifict Babo Amsterdam The Netherlands
Fhrkdayfqx Icyygvjr Gl Geqvft Dg Cfsqmg Cefalu' Italy
Shacuw Tiaruoeohel Ox Turku Finland
Ntygb Cqweicy Sxkfado Gjik Erbach Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

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

Investigated Diseases:

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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