clinical studies

 new treatments 

There is currently no cure for Alzheimer's disease. In recent years, many types of treatments have been developed, but even those that seemed promising in animal experiments have failed so far. One explanation for the failure of studies is that starting treatment for a person who has already been diagnosed with the disease is too late. Therefore, studies today try to define who are the people at risk for the disease so that they can be given treatment that will prevent or delay the onset of the disease.

Update regarding the drug Lecanemab

The drug was developed by Eisai and marketed under the name Leqembi. The drug was approved by the FDA initially under an accelerated process in January 2023. In July 2023, Leqembi became the first-ever drug to receive full FDA approval for the treatment of Alzheimer's disease with an amyloid clearance mechanism using antibodies. Leqembi was registered for use in Israel in July 2024. The EMA (European Medicines Agency) has not approved the drug for marketing in Europe. Leqembi was tested in a multicenter, double-blind study in 1795 patients diagnosed with Alzheimer's disease with a severity of moderate cognitive decline or mild dementia. 
The results of the CLARITY-AD study, which lasted 18 months, demonstrated a slowdown in the rate of cognitive and functional decline in patients on lecanamba (by 27% in the cognitive index and 37% in the functional index). This figure is equivalent to a delay in progression of about six months during the months of the study. A substudy, which examined the effect of lecanamba on the amyloid protein load in brain tissue, demonstrated significant clearance of the amyloid protein. During treatment, side effects were reported, most of which were related to the administration of the drug by infusion and some were related to the clearance of amyloid from the brain tissue (events of edema and bleeding). It was found that homozygous carriers of the ApoE4 gene (carrying two copies of this gene) are at increased risk of side effects and cerebral hemorrhages. To avoid side effects, brain MRI tests should be performed before and during treatment, in order to identify edema and hemorrhages in the brain tissue and treat accordingly. 
Treatment with Lekambim is available at memory clinics in Israel. The treatment is not included in the health basket. In order to avoid side effects, the appropriate people for treatment must be carefully selected.

Update regarding the drug Aducanumab 

The drug was developed by the pharmaceutical companies Biogen and Eisai. The drug was approved for use by the FDA in June 2021 under an accelerated process. Biogen stopped manufacturing and using the drug in January 2024, and reported that the discontinuation of production was due to financial problems. Aducanumab was the first drug to show both clearance of amyloid deposits from the brain and a slowdown in the rate of cognitive decline in patients diagnosed with mild Alzheimer's disease. Due to inconsistent results in its registration studies, it was not accepted by the medical community, and as mentioned, production of the drug Aducanumab was discontinued.

Hyperbaric chamber treatment for people with dementia

On September 30, 2022, an article was published in the newspaper "Haaretz" regarding the effectiveness of pressure chamber treatments: "Without evidence or medical recommendation - pressure chamber treatment is marketed as a breakthrough" - Ido Efrati. 
"According to the Ministry of Health, hospitals in Israel, led by the Shamir Medical Center, offer pressure chamber treatment for a variety of conditions: from the consequences of stroke, improving cognitive abilities, and even treatments against Long Covid. However, studies and experts show: the data is not sufficiently substantiated, it is about participating in a trial...
As a rule, Shamir tells Haaretz, they do not treat Alzheimer's in a pressure chamber, but the hospital admits that there are exceptional cases in which the treatment "is based on medical discretion that was exercised lawfully and accordingly, while weighing the benefit against the risk in relation to the circumstances of the particular case." Conversations with people who have contacted the hospital reveal that they are asked to send medical material and brain scans to assess their suitability for treatment. Many of them are rejected, but not all. Those who are accepted are forced to pay the best of their money (currently it is 650 shekels for treatment, and many more are needed)...
This result does not necessarily surprise Prof. Yehudit Aharon-Peretz, a senior physician at the Stroke and Cognition Institute at Rambam Hospital. "There is no serious study that has examined people with Alzheimer's or another dementia and shows improvement in cognitive functions, except for two works published by Shai Efrati," says Aharon-Peretz, who is also co-chair of the scientific council of the EMDA Association for Dementia and Alzheimer's Patients and Their Families. "What is in these works is very small and preliminary and has not been replicated in other studies. It is at best in its infancy."