Alzheimer’s Clinical Trials

This morning I received notice of a press release about the results of a recently completed clinical trial for Alzheimer’s. As someone who is participating in a number of various studies, I was of course quite interested – especially when I found that this trial was of the same drug that I have recently agreed to participate in a clinical trial for.

Here is a link to the press release - https://investors.biogen.com/news-releases/news-release-details/lecanemab-confirmatory-phase-3-clarity-ad-study-met-primary

Here is a link to a comment on this result from the principals at Penn Medical Center where I have been participating in studies - https://pennmemorycenter.org/lecanemab/

As Dr. Wolk notes, “This is an extremely encouraging development…” And as Dr. Karlawish notes, “in the history of Alzheimer’s disease, I hope that Tuesday, September 27^th, 2022 will become one of the great events.”

While I agree with those comments, the clinical trials will continue. The one that is mentioned in this press release lasted for 18 months and showed that the drug caused slower declines. But more study is needed. The trial that I have signed up has further aspects that will be studied. Primarily, this study is looking at individuals who do not yet show any MCI (Mild Cognitive Impairment) where the one in the news release studied those who already had symptoms of Alzheimer's. But there are additional differences as well. First, the study population will be divided into two groups – one with intermediate level of the amyloid plaque and one for those with a more elevated level.  And while this first study gave the participants infusions on a bi-weekly basis, the trial that I have signed up will have a bi-weekly infusion for those with elevated plaque and monthly for those with only an intermediate level. Both options will last for four years.

[Amyloid Plaques]

 

AHEAD Study

For those who are interested, here is further information about the study that I have signed up to participate in - https://pennmemorycenter.org/research/open-research-studies/ahead/.

Right now, I am in the multi-stage qualification process. There are several aspects of this qualification process. Here is a summary from the consent form I signed this summer:

Stage 1A – blood biomarkers

This stage is for evaluation of the blood biomarkers to see if I have the APOE4 gene which is an indicator that I am susceptible for Alzheimer’s. If I did not, then I would not be eligible to move forward with the screening process, but since I am already scheduled for my 1B visit, this is confirmation that I must have the APOE4 gene. (For more info see https://www.nia.nih.gov/news/study-reveals-how-apoe4-gene-may-increase-risk-dementia)

Stage 1B – questionnaires and test of memory and thinking

This evaluates my mental skills pre-study and establishes a baseline against which future yearly tests can be compared. I’ve done these before for other studies – they are intense, but I am prepared for them.

Stage 2 – Amyloid PET scan

Looks for whether the amyloid plaques are present in the brain at the intermediate or elevated levels or if they are not present. Those with the intermediate level participate in one trial that has once-a-month infusions, those with the elevated level are in a separate trial that has twice-a-month infusions. If there are no amyloid plaques available, then the person is ineligible.

Stage 3 – learn the PET scan result and the blood biomarker result

The person is able to withdraw at this point if they desire. Otherwise, they will sign the consent form for the appropriate arm of the study.

Stage 4 – MRI Scan

Looks for any issues that might make the person ineligible. Since I’ve already had one of these for another study, I don’t anticipate any issues here.

Stage 5 – Tau PET scan and optional Lumbar puncture

Two other things that are associated with those who have Alzheimer’s. The Tau tangle does not have levels associated with it at this time, but is monitored during the study. The lumbar puncture (which I have already had for another study) tries to measure directly the level of amyloid plaques in the brain fluid and they can compare those results to the PET scan in stage 2.

 

Once I’ve gone through all the above stages (and at this point I am expecting that I will continue to qualify for the study), then the periodic infusions will take place for the next four years.

One of my initial concerns was the number of visits that this study would require me to travel to Philadelphia where the research is taking place. This has been alleviated through two different means. First, they are now offering a Lyft service so that I can ride instead of drive for all the necessary visits to Philly. Secondly, while all the stages of the testing will be in Philly as well as the first few infusions (so they can observe any side-effects if there are any), after that they will have a visiting nurse who can do the infusions in the home (this will save not only the travel, but all the time needed with an hour+ each way for just a short infusion). I’ll still have to go to Philly at least once a year, but that’s not much compared to having to do it monthly or bi-weekly.

As I noted above, I’ve already going through stage 1a and my stage 1b visit is scheduled for 3 weeks from now. I recognize that no study is without a certain amount of risk, but I believe that the risk (which they have ensured I understand) is far less that the potential benefit – perhaps for me, but even more importantly for others in the future.

 

The other studies (which are not clinical trials of drugs) are also continuing. I do one of them online every two months (Web APT). Another is annual and requires a trip to Philly for mental evaluation (ABC – Aging Brain Cohort). And I recently received an invitation for a second occurrence of the MTL (medial-temporal lobe) study when I am in Philly for the ABC study. I did this combination ABC-MTL visit last year so I’m expecting several hours of very intense mental activity for the two back-to-back. So far, I have not shown any reduced mental acuity in any of these tests. But the future is always uncertain. My father did not show any obvious symptoms until he reached his 80s. So, I will continue on.

 

Bottom line – you can pray for me as I go through this clinical trial. But also I encourage you to participate in these types of trials if you have the opportunity.