Studying safety & efficacy of new drug for early Alzheimer’s

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    What is this study about?

    This study involves a new drug called AL-101(Alector) (GSK4527226). It is intended for people suffering from the early stage of Alzheimer’s disease. We will give some people with Alzheimer’s disease a drug and others a neutral drug (placebo). Scientists want to see if the new drug is better. Doctors use scoring systems to check a drug’s effectiveness. One way is through the CDR-SB score, which tests things like memory or problem-solving. Patients must score from 0 to 18 points. Higher scores mean they have more difficulties. Another way to check it is iADRS – it is a composite score that measures cognitive properties and functions. It is a combination of two tests called ADAS-Cog14 and ADCS-iADL. They test your thinking ability and ability to perform everyday activities. Higher scores mean they have more problems. Doctors also use ADAS-Cog14, ADCS-ADL-MCI, and ADCS-iADL separately to check for the same things, and ADCOMS to see how brain function changes over time.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Helsinki , Finland

      Kuopio , Finland

      Oulu , Finland

      Turku , Finland

      Bron , France

      Lille Cedex , France

      Nice , France

      Paris , France

      Paris , France

      Saint-Herblain , France

      Strasbourg , France

      Toulouse , France

      Villeurbanne , France

      Muenchen , Germany

      Erbach , Germany

      Koeln , Germany

      Muenster , Germany

      Roma , Italy

      Genova , Italy

      Baggiovara , Italy

      Cefalu00f9 , Italy

      Mondino , Italy

      Brescia , Italy

      Milano , Italy

      Milano , Italy

      Monza , Italy

      Palermo , Italy

      Perugia , Italy

      ‘s-Hertogenbosch , Netherlands

      Amsterdam , Netherlands

      Zwolle , Netherlands

      Bergen , Norway

      Drammen , Norway

      Oslo , Norway

      Stavanger , Norway

      Pozuelo De Alarcu00f3n , Spain

      San Sebastian , Spain

      Barcelona , Spain

      Getxo , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Pamplona , Spain

      Salamanca , Spain

      Terrassa (Barcelona) , Spain

      Valencia , Spain

      Ju00f6nku00f6ping , Sweden

      Malmu00f6 , Sweden

      Mu00f6lndal , Sweden

      Stockholm , Sweden

      Birmingham , United Kingdom

      Bristol , United Kingdom

      London , United Kingdom

      London , United Kingdom

      London , United Kingdom

      Motherwell , United Kingdom

      You can join this study in:

      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      The steps that patients need to take in this clinical trial involve several criteria that must be met for participation and continuation in the study. Below are key inclusion criteria and steps that need to be taken by participants:

      1. Diagnosis: Participant must be within the Alzheimer’s continuum, either with Mild Cognitive Impairment (MCI) due to Alzheimer’s disease (AD) or mild AD dementia.
      2. Amyloid Positivity: Evidence of amyloid positivity either via positive PET scan read by a central imaging lab, or CSF amyloid beta test indicative of amyloid positivity.
      3. Clinical Severity: Must have Mini-Mental State Exam (MMSE) scores of 21-29, CDR-global score of 0.5 to 1.0, a positive CDR Memory Box score and other specific cognitive criteria.
      4. Medication Stability: If on symptomatic AD medications like an Acetylcholinesterase inhibitor (AChEI) or memantine, the dose must be stable for at least 12 weeks before screening. Other medications for AD-related symptoms or conditions must have stable dosing for at least 4 weeks before screening.
      5. Body Weight and BMI: Must have a body weight of ≥45 kg and ≤120 kg with a BMI between 17 and 34.9 kg/m2.
      6. Reproductive Health: Female participants must not be pregnant or breastfeeding and adhere to contraception requirements if of childbearing potential. Male participants must also follow contraception requirements.
      7. Informed Consent: Must be willing and able to give informed consent and comply with study requirements and restrictions.
      8. Study Partner: Availability of an adult person who has frequent contact with the participant to provide accurate information on cognitive and functional abilities and agrees to provide information during clinic visits.

      In addition to the above, there are specific exclusion criteria in place, including but not limited to:

      1. Other neurological conditions besides AD that may contribute to cognitive impairment.
      2. Vascular diseases or history of stroke that could affect cognitive function.
      3. Suicidal behavior or ideation.
      4. Substance use disorders.
      5. Specific criteria related to MRI findings.
      6. Other chronic conditions, immunosuppressive therapy, or planned surgeries that would require general, spinal, or epidural anesthesia during the study.
      7. Key exclusionary medications taken within specified timeframes before screening.

      Please note that this is not an exhaustive list of steps and criteria, and participants should discuss their individual situation with the clinical trial team for precise guidance on what actions they need to take as part of the study.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To be eligible to join the study based on disease criteria, you must be:

      1. In the Alzheimer’s continuum as defined by the 2018 National Institute on Aging and Alzheimer’s Association (NIA-AA) Research Framework corresponding to the clinical categories of Mild Cognitive Impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia.

      However, you will be excluded from the study if you have:

      1. Any neurological condition other than AD that may contribute to cognitive impairment
      2. A history or presence of vascular disease that has the potential to affect cognitive function
      3. A history or presence of stroke within the past year or recent transient ischemic attack within 180 days before screening
      4. A history of severe, clinically significant central nervous system (CNS) trauma
      5. A history or presence of intracranial tumor
      6. Ongoing infections that may affect brain function or a history of infections that resulted in neurologic sequelae.

      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Inclusion Criteria:

      1. Alzheimer’s continuum participation: Participant must be in the Alzheimer’s continuum as defined by the 2018 National Institute on Aging and Alzheimer’s Association (NIA-AA) Research Framework. This corresponds to the clinical categories of Mild Cognitive Impairment (MCI) due to Alzheimer’s Disease (AD) and mild AD dementia. MCI refers to a slight but noticeable and measurable decline in cognitive abilities, including memory and thinking skills, that is greater than expected for an individual’s age and education level.
      2. Amyloid positivity: Participant must have evidence of amyloid positivity either by:
        • Positive positron emission tomography (PET) result: Amyloid PET scans must be read by a central imaging lab.
        • Cerebrospinal fluid (CSF) amyloid beta (Aβ) test result indicative of amyloid positivity: A CSF test analyzing the levels of amyloid beta, a protein that can clump in the brains of people with Alzheimer’s disease.
      3. Clinical severity: Participants must also meet the following criteria for clinical severity:
        • MMSE score of between 21 and 29 points: The Mini-Mental State Examination (MMSE) is a commonly used test of cognitive function among the elderly, which includes tests of orientation, attention, memory, language and visual-spatial skills.
        • CDR-global score (GS) of 0.5 to 1.0: Clinical Dementia Rating (CDR) is a numeric scale used to quantify the severity of symptoms of dementia.
        • CDR Memory Box score greater than or equal to (≥) 0.5.
        • Objective impairment in episodic memory indicated by at least 1 standard deviation below age-adjusted mean in the Wechsler Memory Scale-IV Logical Memory II (WMS-IV LMII): A test that measures different types of memory and is often used to assess memory functions in individuals with cognitive impairment.
      4. Stable medication regimen: If the participant is receiving symptomatic AD medications such as an Acetylcholinesterase inhibitor (AChEI) or memantine, the dosing regimen must have been stable for at least 12 weeks prior to screening and is not expected to change during study participation.
      5. Weight and Body Mass Index (BMI): Body weight ≥45 kilogram (kg) and ≤120 kg with a BMI between 17 and 34.9 kg/m².
      6. Contraception requirements:
        • A female participant is eligible to participate if she is not pregnant or breastfeeding, and if of child-bearing potential, she follows contraception requirements outlined in the protocol.
        • A male participant is eligible to participate if he follows contraception requirements outlined in the protocol.
      7. Informed consent: Willing and able to give informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
      8. Study partner availability: Availability of an adult person who has frequent and sufficient contact with the participant, is able to provide accurate information regarding the participant’s cognitive and functional abilities, agrees to provide information at clinic visits, and signs the ICF of the study partner.

      These criteria provide a framework to ensure that participants are suitable for the study and have the ability to follow the study protocols and procedures .

      What Reasons Could Exclude Me from the Study?

      Here is a list of conditions that would exclude a participant from the study, along with explanations of medical terms where relevant:

      1. Neurological conditions other than Alzheimer’s Disease (AD): Other brain disorders that might impact cognitive function.
      2. Vascular disease: Diseases of the blood vessels that could affect brain functions, such as cognitive abilities.
      3. Recent stroke or transient ischemic attack: A stroke within the past year or a brief stroke-like event within 180 days before screening.
      4. Severe CNS trauma: A significant injury to the brain or spinal cord.
      5. Intracranial tumor: A brain tumor.
      6. Ongoing or past infections affecting brain function: Infections that may influence brain processes or have resulted in lasting neurological effects.
      7. Primary psychiatric diagnosis: A mental health disorder that might interfere with study assessments.
      8. Recent or current high-risk suicide behavior: Assessed using the Columbia Suicide Severity Rating Scale (C-SSRS).
      9. Substance use disorder: Alcohol or drug abuse within the past two years.
      10. Findings on MRI scans: These include multiple small strokes, significant strokes, severe brain vessel disease, large brain bleeds or areas of bleeding, swelling caused by fluid leakage from blood vessels, traumatic brain damage, and significant structural brain abnormalities.
      11. Tuberculosis risk: Previous exposure to or infection with tuberculosis that requires screening.
      12. Chronic active immune disorders: Requiring immunosuppressive therapy, which reduces the activity of the immune system, within six months prior to screening.
      13. Abnormal serum vitamin B12, folate, or TSH levels: Indicators of potential nutritional deficiencies or thyroid problems.
      14. Diabetes control: Uncontrolled diabetes as shown by a high Hemoglobin A1c level, indicating average blood sugar levels are too high.
      15. History of cancer: Except for specific non-melanoma skin cancers.
      16. Severe allergies to certain medications: Known intense adverse reactions to chimeric, human, or humanized antibodies or fusion proteins.
      17. Planned surgery: If it requires general, spinal, or epidural anesthesia during the study period.

      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The clinical trial involves the drug known as GSK4527226. Unfortunately, the active substance for GSK4527226 is not directly listed in the provided document, but the drug is administered in the study. Please note that proprietary names like GSK4527226 often refer to the investigational code for the substance being studied, and the actual active substance may only be revealed once the trial progresses or completes, especially in the early phases of clinical trials like this Phase 2 study.

      The trial also involves a Placebo which is a substance that has no therapeutic effect and is used as a control in testing new drugs.

      To provide you with a brief description of the active substances typically involved in Alzheimer’s medication, here are examples of the active substances used in approved drugs for the treatment of Alzheimer’s Disease:

      1. Donepezil – This is a cholinesterase inhibitor that works by increasing the levels of a neurotransmitter called acetylcholine which is involved in memory and judgment.
      2. Rivastigmine – Similar to donepezil, it is a cholinesterase inhibitor that enhances cholinergic function by increasing the concentration of acetylcholine through reversible inhibition of its hydrolysis by cholinesterase.
      3. Galantamine – It also works as a cholinesterase inhibitor but is also thought to modulate activity at nicotinic receptors which may contribute to its effects.
      4. Memantine – This drug acts on the glutamatergic system by blocking NMDA receptors, which may contribute to the symptoms of Alzheimer’s disease when overactivated.

      If the study drug GSK4527226 progresses through the clinical trial phases and is approved, more specific information regarding its active substance and mechanism of action will likely be disclosed.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The active substance being tested in the clinical trial is known as GSK4527226 (AL101). Here is the requested information:

      1. GSK4527226 (AL101): This is a novel substance undergoing clinical trials to assess its efficacy and safety in participants with early Alzheimer’s Disease. As of now, and based on the information provided in the trial details, it is being administered to participants as part of this research, indicating that it is a substance currently under investigation. This suggests that it may not yet be widely known in medical literature outside the context of research studies like this one.

      Study ID

      CT-EU-00036786

      Recruitment status

      Recruting new patients

      Start of the trial

      8 months ago

      Study phase

      Phase
      II

      Medicinal Product