Lecanemab (marketed now as Leqembi ) "approved" today

The Lord is my strength and my shield; in Him my heart trusts, and I am helped; my heart exults, and with my song I give thanks to him. Psalm 28:7

There is a lot to discuss here, but here is some primary thoughts on today’s approval of Lecanemab:

The study info:
https://www.nejm.org/doi/full/10.1056/NEJMoa2212948
and
https://clinicaltrials.gov/ct2/show/NCT03887455

FDA Statement:

https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment

NY Times article:
https://www.nytimes.com/2023/01/06/health/alzheimers-drug-leqembi-lecanemab.html

“The main positive outcome of that trial was that patients receiving Leqembi declined more slowly over 18 months — by less than half a point, 0.45, on an 18-point cognitive scale that assesses functions like memory and problem-solving — than patients receiving a placebo. (Patients on Leqembi declined by 1.21 points, while patients on placebo declined by 1.66 points.) That amounts to a 27 percent slower decline.”
Explanation of the cognitive scale used:
https://www.frontiersin.org/articles/10.3389/fnagi.2022.1021792/full

“CDR-SB is a numeric scale used to quantify the various severity of symptoms of dementia. Based on interviews of people living with AD and family/caregivers, qualified healthcare professionals assess cognitive and functional performance in six areas: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The total score of the six areas is the score of CDR-SB, and CDR-SB is also used as an appropriate item for evaluating the effectiveness of therapeutic drugs targeting the early stages of AD.”

Side effects:
“The incidence of amyloid-related imaging abnormalities-edema/effusion (ARIA-E), an adverse event associated with anti-amyloid antibodies, was 12.5% in the lecanemab group and 1.7% in the placebo group. The incidence of symptomatic ARIA-E was 2.8% in the lecanemab group and 0.0% in the placebo group. The ARIA-H (ARIA cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis) rate was 17.0% in the lecanemab group and 8.7% in the placebo group. The incidence of symptomatic ARIA-H was 0.7% in the lecanemab group and 0.2% in the placebo group. There was no imbalance in isolated ARIA-H (i.e., ARIA-H in patients who did not also experience ARIA-E) between lecanemab (8.8%) and placebo (7.6%). The total incidence of ARIA (ARIA-E and/or ARIA-H) was 21.3% in the lecanemab group and 9.3% in the placebo group. Overall, lecanemab’s ARIA incidence profile was within expectations. “
Bottom line:

There are signs that pre-symptomatic and and early-stage patients can have the disease slowed in progression by up to 27%.
There are side effects and some would need to be treated and/or could result in ceasing the drug’s use.
Is it a cure? No. It does a good job clearing Beta Amyloid plaque, but the jury is still out just how much this plaque “causes” the disease, but it certainly appears that if you reduce it to nearly zero, which this drug seems to, it helps.
Is it a step in the right direction? Absolutely!

I am not a doctor, I am an IT Technician. Stay in contact with your primary care physician and neurologist for availability and more info. Keep an eye on Alz.org and/or the Science Hub app for more info as it comes out. The side effects can be serious and many likely won’t prescribe it, especially at what is expected to be a high cost ($26,500/year). It is yet to be determined how Medicare will deal with it, but I wouldn’t be surprised if it is treated like Aduhelm. The Alzheimer’s Association is fighting hard for full coverage by Medicare. If so, the only place you will be able to receive it is at an ADRC (Alzheimer’s Disease Research Center). Here is the list of them should that be the case:
https://www.nia.nih.gov/health/alzheimers-disease-research-centers

Alz.org statements:

https://www.alz.org/news/2022/alzheimers-association-statement-on-lecanemab-phas

More papers and statements coming soon…There are more, similar studies in the works that are getting close to resolution as well.