New drug masitinib could slow Alzheimer's decline
NCT ID NCT05564169
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 3 trial tests whether masitinib, a drug that targets immune cells in the brain, can slow cognitive decline in 600 people with mild Alzheimer's. Participants take masitinib or a placebo alongside standard Alzheimer's medications. The study lasts 24 weeks and measures changes in thinking and daily function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- masitinib
- What this could lead to
- If it works, this could point toward a new treatment option to slow cognitive decline in people with mild Alzheimer's disease.
- What could go wrong
- This is an early Phase 3 trial, and previous studies of similar drugs have failed. Masitinib may not show benefit, and side effects from the drug are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 600 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Jun 2026
An estimate. Start dates often move.
- Expected to finish
-
Dec 2029
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
50 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Main inclusion criteria include: 1. Patient with clinical diagnosis of Alzheimer's disease based on criteria defined by IWG (International Working Group on Alzheimer's disease) at screening visit. 2. Patients with ADCS-ADL score at screening visit and baseline visit \< 73 3. Patient with MMSE ≥ 21 and ≤ 25 at screening visit and baseline visit. 4. Patient with Alzheimer's Disease biomarker profile at screening visit: * A positive amyloid PET scan * Alternatively, positive a-beta AND p-tau results OR an abnormal p-tau/a-beta ratio in CSF analysis. Before randomization, the results will be verified centrally. 5. If patients are treated with cholinesterase inhibitors (donepezil, rivastigmine or galantamine), and/or memantine. They should have been at stable dose for a minimum of 6 months at baseline visit, with no changes foreseen in therapy throughout the trial. 6. If receiving a supplement for cognition (eg, gingko biloba, omega-3 polyunsaturated fatty acid, vitamin E, curcumin, souvenaid) patients must have been taking it at stable dose for at least 4 months prior to screening visit. 7. Patients with a caregiver who, at screening and baseline visits, agrees to accompany the participant to all trial visits, supervise compliance with procedures, provide detailed information, has sufficient contact (≥1 hour/day for ≥3 days/week or as deemed sufficient by the Investigator), can read, understand, and speak the designated language, and is cognitively capable of fulfilling trial requirements. Main exclusion criteria include: Related to disease 1. Patients with any other cause of dementia shown by MRI findings and neurological examination 2. Systemic conditions known to cause dementia, e.g., hypothyroidism, untreated vitamin B12 or folic acid deficiency, niacin deficiency, neurosyphilis, HIV infection at screening visit. 3. Patients with substance-induced dementia, Alzheimer's disease with delirium, severe delusions (e.g., NPI delusion score ≥ 4), psychosis or antipsychotic use, or a history of significant psychiatric disorders at the screening visit. 4. Patients with a significant unexplained improvement or decline in overall status on ADAS-Cog and ADCS-ADL at screening and baseline compared to previous assessments, and those whose scores are not in line with their medical history.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Alzheimer disease are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
9 sites in 2 countries. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Ace Alzheimer Center Barcelona (Fundació ACE)
Barcelona, Spain
-
Complejo Asistencial de Zamora. Hospital Provincial de Zamora
Zamora, Spain
-
Hospital Clinico Universitario Virgen de la Arrixaca
Murcia, Spain
-
Hospital Policlínico de Gipuzkoa
Donostia / San Sebastian, Spain
-
Hospital Universitario Nuestra Señora del Perpetuo Socorro de Albacete (Hospital Universitario Nuestra Señora del Perpétuo Socorro)
Albacete, Spain
-
Hospital Universitario de Navarra
Pamplona, Spain
-
Institut de la mémoire et Maladie d'Alzheimer, Hôpitaux Universitaires Pitié-Salpêtrière
Paris, France
-
La Paz University Hospital (Hospital Universitario La Paz)
Madrid, Spain
-
Virgen de las Nieves University Hospital (Hospital Universitario Virgen de las Nieves)
Granada, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Gut bacteria may hold clues to dozens of diseases
- Can a massive data registry crack the code of Parkinson's and related brain diseases?
- Can a gentle electric current calm the mind in Alzheimer's?
- Alzheimer's vaccine aims to clear amyloid before memory fades
- Blood, eye, and brain scans team up to spot Alzheimer's earlier
- Can a home device slow Alzheimer's? pilot study tests pulsed electromagnetic therapy