Informations générales (source: ClinicalTrials.gov)
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Masitinib as add-on Therapy in Patients With Mild Alzheimer's Disease, Treated With Standard of Care
Interventional
Phase 3
AB Science (Voir sur ClinicalTrials)
juin 2026
décembre 2029
02 novembre 2025
Masitinib is an orally administered tyrosine kinase inhibitor that targets activated
cells of the neuroimmune system (mast cells and microglia). Study AB21004 will evaluate
masitinib as an adjunct to cholinesterase inhibitor and/or memantine in patients with
mild-to-moderate Alzheimer's disease.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Institut de la mémoire et Maladie d'Alzheimer, Hôpitaux Universitaires Pitié-Salpêtrière - Paris - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
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.