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Study of VHB937 to evaluate its effects on cognition and function in people with early Alzheimer's Disease over 72 weeks

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on studying Alzheimer's Disease, a condition that affects memory and cognitive function. The study will test a new medication called VHB937, which is given as a concentrate for solution for infusion through intravenous administration. The purpose is to evaluate how well this new treatment works on thinking ability and daily functioning in people with early stages of the disease.

The study will compare VHB937 with placebo over a period of 72 weeks, followed by an extension period. During the study, participants will receive regular infusions of either the study medication or placebo. The study will include people who have early Alzheimer's Disease, including those with Mild Cognitive Impairment due to Alzheimer's.

Throughout the study, doctors will monitor changes in participants' ability to think and perform daily activities. They will use various tests to measure memory and thinking skills, including the Clinical Dementia Rating scale. Participants will undergo regular health checks, including brain MRI scans, to ensure safety. Some participants may continue taking their regular Alzheimer's medications during the study if they were already using them before joining.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    You will undergo initial evaluation to confirm eligibility for participation in the 72-week study of VHB937 for early Alzheimer's disease

    Your age should be between 50 and 85 years, with body weight not exceeding 180 kg

    A brain scan or spinal fluid test will confirm the presence of Alzheimer's disease markers

    Your mental function will be assessed using specific tests, including the Clinical Dementia Rating (CDR) scale

  2. Step 2

    Study partner requirement

    You need to have a reliable person who can accompany you to study visits

    This person will help provide information about your daily activities and function

  3. Step 3

    Medication requirements

    If you are currently taking memory medications, you must maintain a stable dose for at least 12 weeks before starting the study

    If you stopped taking these medications, this must have been at least 12 weeks before starting the study

    You can also participate if you have never taken these medications

  4. Step 4

    Treatment period

    You will receive either VHB937 or a placebo through intravenous infusion

    The study will last for 72 weeks (approximately 1.5 years)

    Regular assessments will track changes in your memory and daily function

    Blood samples will be taken at specific times to measure drug levels

  5. Step 5

    Monitoring and safety

    Regular brain scans will be performed to monitor your safety

    Your health will be monitored through laboratory tests, vital signs, and heart recordings (ECG)

    Any side effects will be recorded and assessed

    Mental health assessments will be conducted throughout the study

Who can join the trial?

10 criteria

  • Age between 50 and 85 years old with body weight not exceeding 180 kilograms
  • Diagnosed with Mild Cognitive Impairment (MCI) due to Alzheimer's disease or mild Alzheimer's disease
  • Must have a Clinical Dementia Rating (CDR) score of 0.5 or 1.0 during initial screening and baseline assessment (This scale measures the severity of dementia symptoms)
  • Must achieve a specific score on the ADAS-Cog14 test during screening (This is a test that measures thinking abilities)
  • Must have confirmation of Alzheimer's disease through either:
    • Spinal fluid testing, or
    • Brain imaging that shows amyloid deposits
    • Must have a reliable study partner who can attend appointments when needed
    • If taking memory medications (AChEI or memantine):
      • Must be on a stable dose for at least 12 weeks before starting the study, or
      • Must have stopped taking these medications at least 12 weeks before starting the study
      • Both men and women can participate

Who cannot join the trial?

15 criteria

  • History of any other type of dementia (a decline in mental ability) other than Alzheimer's disease
  • Current participation in other clinical trials or within 30 days before this study
  • Severe liver or kidney disease
  • History of stroke or brain hemorrhage
  • Uncontrolled high blood pressure
  • Active cancer or cancer treatment within the past 5 years
  • History of seizures or epilepsy
  • Severe depression or other major psychiatric disorders
  • Regular use of medications that can affect brain function
  • Alcohol or substance abuse within the past 2 years
  • Inability to undergo MRI (magnetic resonance imaging) scans
  • Presence of metal implants or pacemakers
  • Inability to provide informed consent
  • Pregnancy, breastfeeding, or planning to become pregnant
  • Known allergies to the study medication or its components
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Investigated drugs

VHB937 is an investigational medication being studied for the treatment of early Alzheimer's Disease. It is being tested to see if it can help improve thinking abilities (cognition) and daily functioning in people with early stages of Alzheimer's Disease. The medication is being compared to a placebo to determine how well it works and to evaluate its safety over a period of 72 weeks, followed by an extension period.

What is already known about the treatment

VHB937 - An investigational medication being studied for the treatment of early Alzheimer's Disease in clinical trials. The drug is being evaluated for its effects on cognitive function and daily activities in patients, though its specific mechanism of action is not publicly disclosed in the current medical literature. This experimental treatment is being tested through a 72-week randomized, placebo-controlled study to determine its efficacy and safety profile in patients with early-stage Alzheimer's Disease. The medication represents a new potential therapeutic option in the field of neurodegenerative disorders, with ongoing research to establish its clinical benefits and safety parameters.

Investigated diseases

Alzheimer's disease - A progressive brain disorder that gradually destroys memory and thinking skills. The disease begins slowly with mild memory problems and confusion, then progressively affects more complex mental functions. Over time, individuals experience increasing difficulties with daily tasks, communication, and recognizing people. The condition involves the buildup of abnormal protein deposits in the brain, leading to the death of brain cells. Changes in personality and behavior often occur as the disease advances. The disease primarily affects older adults, though early-onset cases can occur in younger people.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516966-12-00Protocol codeCVHB937A12201Estimated enrolment407 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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