New clinical trial for MCI

Michele P

https://www.brightfocus.org/resource/the-ahead-study-can-alzheimers-be-prevented-or-slowed-before-symptoms-begin/

LBC83

This is not a "new trial". Per the article, the AHEAD trial finished their enrollment in October 2024, and it is a four-year trial. So around late 2028, they should start to get results from the trial. The idea is that starting Leqembi very early, before any cognitive decline, may result in amyloid clearance with the result that cognitive decline may be prevented. In simple terms, you might consider this a cure for AD, if this strategy works. Hence the title for the article "The AHEAD Study: Can Alzheimer's Be Prevented or Slowed Before Symptoms Begin?"

LBC83

The article does briefly discuss the Alzheimer's Tau Platform (ATP) Clinical Trial. This is a trial lead out of the University of California San Francisco (UCSF) by Dr. Boxer. Back in April 2024 when I was diagnosed with AD, I considered joining this trial instead of starting on Leqembi. After consulting with my Neurologist, they suggested that I contact Dr. Boxer to determine the status of the trial. So I did, and he replied the trial was delayed, and I started Leqembi infusions. Fast forward to today. I recently had my 40th Leqembi infusion. I just checked the ATP website, they are still not yet enrolling participants for their trial. Apparently they have experienced significant delays in getting the trial started.

The concept behind the trial is fascinating. They plan to test anti-tau drugs by themselves and in combination with an anti-amyloid drug (i.e. Leqembi or Kisunla). One idea that attracted me was a proposal that they might not include a placebo group, as some suggested that would be unethical given FDA approval of Leqembi & Kisunla. I'm not sure what the current plans are for the ATP with regards to placebo.

GEH

Hi LBC83, (and anyone else willing to share Leqembi experiences)

Totally off subject, but you noted that you just completed your 40th Leqembi infusion. (wow, congrats!!) I am curious how you feel it has or not helped with your cognitive abilities. I am about to take my 6th infusion and I am amazed at the sense of clarity+ I feel. I have been a few years feeling as if I was thinking through thick fog... if that makes sense. I cannot think of another way of explaining. It feels, with the last few infusions that I have gained significant mental clarity.... Memory that has been lost is still gone but my clarity of thought processing has increased greatly. For example I regularly meet with a group of about 7 friends for supper. For the last probably two years I have been unable to follow the conversations had round the table nor have I been able to contribute to them. However, the most recent meetup, was significantly different. I am also an artist and have always made my Christmas presents... but for the last couple years because I did not make any because I could not find my "inspiration". However, this year, I was able to find my inspiration and I just realized why. For the last two + years I was not able to "see my minds eye"...My "minds eye" was solid black, no images, colors, no visual memories etc. I could not imagine in my minds eye what my art project was going to look like and therefore I could not create. BUT!!! This year I could... It was miraculous!! Have you (or anyone else reading this) had any similar improvements from Leqembi infusions and if so, does it just get better and better the longer I am on it? I realize that the brain cells that have died due to the plaque will not return but will I continue to see improvements or will they start leveling off etc. (Sorry for going on so long. Thanks for listening)

GE

GEH

Oh, Also I would like to Wish Everyone the Best of New Year 2026!! 💖

Dorse

Thank you for sharing your experience with the infusions. I am scheduled to start Kisunla infusions this month. I am still feeling quite concerned about getting the infusions. I would like to see more people share their experience with the infusions.

JJ401

Dorse, husband here just finished Kinsula infusion #12. They went really well. He had no side effects. Next up is a PET scan and then… depending on the scan results we were told it’s either 6 more infusions or stopping.

Dorse

Thank you so much for sharing this info about your husband's kinsula infusions. I wish more people would share their experience with this infusion as I'm scheduled to start on Jan. 26.

cahippy

I am a new-be to this site. I would also like to hear more about the kinsula infusions. My mom's doctor said 'no' but it appears if there is proper follow up/scans, it could be helpful. Thanks!

LBC83

https://alzconnected.org/discussion/comment/262155#Comment_262155

I'm glad to hear that you have had a very good experience with Leqembi.

As a reminder for general readers, the Phase 3 trials for Leqembi & Kisunla included everybody getting periodic cognitive tests. The researchers then computed the cognitive decline for those receiving the active drug (Leqembi or Kisunla) and compared these numbers with the cognitive decline for those on placebo. For the average Jane/Joe receiving anti-amyloid infusions, they experienced slower cognitive decline compared to those on placebo.

I fully understand the rationale behind questions about cogntiive decline for those receiving anti-amyloid medication. As an Engineer by training, I always struggle to reply to this question. For me, a proper answer would require me to project my cognitive decline if I had not started on Leqembi, and then compare that with my cognitive decline I've actually experienced. I'd have no idea as to how to estimate the former (what cognitive state I might be in today if I had not started on Leqembi).

To further complicate the query, I'm not just on Leqembi, my Doctor also prescribed Aricept. Clinical trials with Aricept showed that it provided an immediate boost in cognition which slowly wears off, but the drug still provides some cognitive benefits over time. So if my cognition went up early in my AD journey, would that be because of the Aricept, or something to do with Leqembi? How would anybody be able to determine how much their cognition has changed due to Aricept vs Leqembi?!?

Going back to Leqembi, the Phase 3 clinical trial included a small group which received period tau PET scans. The researchers found that those who started on Leqembi with low starting tau levels did much better with the drug - high percentages had no cognitive decline and some even experirenced cognitive improvements. Tau is a separate biological process from amyloid plaque. A simple way to keep them separate is that amyloid plaque is found outside neurons, while tau tangles are formed within neurons. It is the tau tangles which eventually destroy the neurons. As a side note, there are clinical trials going on right now combining anti-tau drugs with anti-amyloid drugs. The idea is to provide a 1-2 punch against AD, perhaps stopping the progression of the disease in its tracks.

So people who start on Leqembi (or Kisunla) with low tau levels may experience better results with the drugs, in contrast with those who start on the drugs later in the disease progression when tau levels are higher.

To directly answer your question, I had a second MoCA (Montreal Cognitive Assessment) test about 10 months after starting on Leqembi. I scored the same on the 2nd test (i.e. my cognition was the same as when I started on Leqembi). I take that as a success.

GEH

Thanks for sharing so much LBC83.... Wishing you, and yours, a very good New Year. GE 😊

Dorse

https://alzconnected.org/discussion/comment/262247#Comment_262247

I would like to hear more about the Kisunla infusions also as I am scheduled to start the infusions this month.

LBC83

https://alzconnected.org/discussion/comment/262363#Comment_262363

The technical term for both Kisunla and Leqembi are monclonal antibodies. The prefix "mono" means single, and the term "clonal" refers to a copy of a specific cell. Your body naturally produces antibodies to identify and tag foreign invaders like viruses or bacteria.

As monoclonal antibodies, Leqembi and Kisunla are man-made proteins designed to target specifc cells in your brain. In this case, both drugs are desgined to find, stick to, and help remove amyloid proteins in your brain.

Leqembi & Kisunla infusions are similar. Patients go to in an infusion center, where a needle is inserted into their arm. Over an hour or so, the drugs are infused into your bloodstream while you sit in a chair. After the infusions are complete, there is usually a monitoring period to check for any reactions, and then the patient is dismissed.

One big difference between Leqembi & KIsunla is the infusion frequency: Leqmbi infusions are once every two weeks, while Kisunla infusions are once every four weeks. Another key difference is the length of treatment. Kisunla solely removes amyloid plaque, so after all of the amyloid plaque is gone, treatment with Kisunla is terminated. In the Phase 3 trial with Kisunla, 17% of patients were amyloid clear after 6 months of treatment (so they stopped Kisunla infusions), 47% at 12 months, and 69% were amyloid clear after 18 months of treatment. Nowadays, it is simple to check your amyloid status - a simple blood test will suffice (I recently had a blood test to check my amyloid levels, after 40 Leqembi infusions my brain is now clear of amyloid plaque). Leqembi removes both amyloid plaque and amyloid protofibrils (a precursor to amyloid plaque, which is also damaging to neurons). After 18 months of initial treatment with Leqembi, patients have the option to switch to less frequent maintenance dosing.

Side effects with both Leqembi & Kisunla are similar: there are infusion-related side effects (i.e. a side effect from getting the infusion itself, as opposed to the active drug), and ARIA. Common infusion-related side effects include fever, chills, headache, rash, nausea, vomiting, abdominal discomfort, and elevated blood pressure. Some infusion centers pretreat patients with common over-the-counter medications to prevent these reactions. Other infusion centers wait to see which patients develop infusion-related reactions. I personally have never had an infusion-related reaction. About 1/4 of the people in the clinical trial for Leqembi experienced infusion-related reactions. These reactions usually occurred during the first two treatments and were seen during the infusion or up to several hours after the infusion.

ARIA refers to either brain swelling (ARIA-E) and/or bleeding (ARIA-H) due to the anti-amyloid medication. MRIs are regularly scheduled for those receiving anti-amyloid medications, the purpose of these MRIs is to check for ARIA. Generally speaking, ARIA is typically mild with no symptoms and goes away by itself when infusions are paused. However, some people do experience ARIA with symptoms, including headache, confusion, visual changes, dizziness, nausea, gait difficulty, and seizures. If you review this list carefully and compare it with the list of infusion-related side effects, you can see that some symptoms are common to both. Herein lies the problem. For example, if you have a headache after an infusion, is the headache due to an infusion-related reaction or ARIA? It is not so easy to tell the difference. Again, that is why the MRIs are performed, to check for ARIA. This is also why it is important to understand the signs of ARIA and infusion-related reactions, so you know what you should be reporting to your Doctor.

Dorse

We want to hear more about Kisunla infusions from those who have finished these infusions, their experience with alzheimer's before, during, and after infusions. Both infusions info. in general is readily available via online and Lilly support person. We want to hear more about personal experiences.

wdreitlein

https://alzconnected.org/discussion/comment/262543#Comment_262543

Hi I am also interested in Kisunla Infusions….side effects and any benefits.

Dorse

https://alzconnected.org/discussion/comment/262922#Comment_262922

I was scheduled to start the kisunla infusions on Jan. 26, but I make my final decision to cancel all scheduled infusions and MRI's. I still have to many questions even after all the research. I have had nothing but stress over all of this mild Alzheimer's diagnosis. I regret ever mentiioning anything to do with memory, the MRI, and the Pet Scan. I question how much Lilly's is jumping on this money maker as well as neurologist excited about the first treatment they can offer for alzheimer's. I am still taking care of all my finances, daily routine as before the diagnosis 6 mo. ago. I am 80, and would be close to 82 by the time I finish all the infusions, MRI's etc. ??? I think I would have more questions than answers even if I were younger. All of us who are older are a safe bet for pharmaceutials as we will be gone before any long term study of the side affects. I have decided to continue as I am. It's a personal decision, and yes it's been an ongoing BIG decision for me over these 6 mo. waiting for insurance approval.