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 study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Hospital Universitari General De Catalunya Sant Cugat Del Valles Spain
Etg Neuroscience Sp. z o.o. Warsaw Poland
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Region Oerebro Laen Orebro Sweden
Hospital Santa Maria Della Misericordia Perugia Italy
Pellegrin Hospital Bordeaux France
Katholisches Klinikum Bochum gGmbH Bochum Germany
Fundacio Ace Institut Catala De Neurociencies Aplicades Barcelona Spain
Hospital Universitario Dr Peset Aleixandre Valencia Spain
Policlinica Gipuzkoa S.A. Donostia / San Sebastian Spain
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
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d’Aragona Salerno Italy
Fondazione Istituto G. Giglio Di Cafalu Cefalu' Italy
Neuro Health Centrum s.r.o. Brno Czechia
Revit Sp. z o.o. Bialystok Poland
Dynamikos GmbH Institut fuer Studien zur Psychischen Gesundheit Mannheim Germany
Region Skane Skanes Universitetssjukhus Lund Sweden
Neurohk s.r.o. Chocen Czechia
Pia Fondazione Di Culto E Religione Card G Panico Tricase Italy
Brain Research Center Den Bosch B.V. s-Hertogenbosch The Netherlands
Virgen del Rocío University Hospital Sevilla Spain
Ospedale San Raffaele S.r.l. Milan Italy
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Karolinska University Hospital Solna Sweden
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Centre Hospitalier Universitaire De Nantes Nantes France
Azienda USL Toscana Centro Prato Italy
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Universita Degli Studi Di Brescia Brescia Italy
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Neuroprotect Sp. z o.o. Warsaw Poland
Forbeli s.r.o. Prague Czechia
NZOZ Wrocławskie Centrum Alzheimerowskie Wroclaw Poland
Uqmpcgroem Hdzvpkuu Cbythef Cologne Germany
Apwmnrhzrc Pckqecgv Hcogynro Dr Mjsyybfbn Marseille France
Ugphoun Unbhltgnvm Hkwrcdpl Uppsala Sweden
Uqxebgycxmdcjctmggfmw Mgetqmsv Auc Munster Germany
Kvugupwa Bykhqwvs Gdbj Bayreuth Germany
Kunbajsu dfr Uaznfcigybhy Mdultxxw Adv Munich Germany
Ikyoowdl Zrfylct De Bxrzdygmakjdzphhy Oświęcim Poland

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

Trial status

Country Status Recruitment Start
Czechia Czechia
Recruiting
31.12.2025
France France
Recruiting
31.12.2025
Germany Germany
Recruiting
31.12.2025
Italy Italy
Recruiting
31.12.2025
Poland Poland
Recruiting
31.12.2025
Spain Spain
Recruiting
31.12.2025
Sweden Sweden
Recruiting
31.12.2025
The Netherlands The Netherlands
Recruiting
31.12.2025

Trial locations

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.

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 ID:
2024-516966-12-00
Protocol code:
CVHB937A12201
Trial Phase:
Therapeutic exploratory (Phase II)

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