Masitinib is a medication that targets cells in our brain and immune system that become overactive in Alzheimer's disease. A clinical trial looked at how masitinib works in people with mild-to-moderate Alzheimer's disease when taken with other Alzheimer's medications.
The clinical trial was double-blind, which means that neither the patients nor the doctors knew who was receiving masitinib and who was receiving a placebo (a fake medication). The trial involved 4 groups of patients, each group receiving either masitinib or a placebo. The patients were aged 50 years or older and had a clinical diagnosis of mild-to-moderate Alzheimer's disease.
The trial had multiple primary outcomes, which means that the researchers were looking at multiple aspects of the patients' health to see if masitinib was effective. The first primary outcome was a test called the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog), which measures a patient's cognitive abilities, such as memory, language, and orientation. The second primary outcome was a test called the Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory scale (ADCS-ADL), which measures a patient's ability to perform daily activities, such as bathing, dressing, and using the toilet.
The results of the trial showed that patients who took masitinib (at a dose of 4.5 mg/kg/day) showed a significant improvement in their cognitive abilities, as measured by the ADAS-cog test, compared to patients who took a placebo. Patients who took masitinib also showed a significant improvement in their ability to perform daily activities, as measured by the ADCS-ADL test, compared to patients who took a placebo. The improvement was seen when compared to their own baseline levels. The trial concluded that masitinib may be helpful in treating mild-to-moderate Alzheimer's disease.
The trial also looked at the safety of masitinib. The most common side effects were a rash, a decrease in the number of a certain type of white blood cells called neutrophils, and a decrease in the level of a protein called albumin in the blood. However, these side effects were consistent with what is already known about masitinib's safety profile.
It is important to note that another group of patients in the trial received a higher dose of masitinib (6.0 mg/kg/day) for 12 weeks, but the results were inconclusive. This means that the researchers could not definitively say whether the higher dose of masitinib was effective or not.
Masitinib (at a dose of 4.5 mg/kg/day) showed promising results in improving cognitive abilities and daily activities in patients with mild-to-moderate Alzheimer's disease when taken with other Alzheimer's medications. However, further studies are needed to confirm these findings. It is also important to note that masitinib may cause certain side effects, such as a rash, a decrease in the number of neutrophils, and a decrease in albumin levels in the blood. Patients should discuss the risks and benefits of masitinib with their doctors before starting treatment.
Overall, this trial provides hope for patients with Alzheimer's disease and their families, as it suggests that masitinib may be a helpful addition to current Alzheimer's treatments.