ApoE4.Info

The initial data from Lexeo Therapeutics on their APOE4 homozygous Alzheimer’s disease clinical trial has been released. Of note, they are still enrolling patients and adding 2 more US sites for the trial. To learn more, click this link:

LEXEO THERAPEUTICS ANNOUNCES POSITIVE INITIAL DATA FROM ONGOING PHASE 1/2 CLINICAL TRIAL OF AAV-BASED GENE THERAPY CANDIDATE LX1001 IN PATIENTS WITH ALZHEIMER’S DISEASE

Here's a bit more up-to-date info (more patients) from CTAD:

https://www.nytimes.com/2022/12/02/heal ... erapy.html

Brian

Read a New York Times article yesterday about APOE2 gene therapy for 4/4 homozygotes. Since I am one of the admins of the APOE4/4 group on Facebook, I emailed one of the doctors (Dr. Samuel Gandy) last night and he responded this morning, introducing me to the research team at Weill Cornell. Dr. Michael Kaplitt then emailed me with the following:
"We certainly would love to interact with your members since this is the group that we are trying to help at present. The major criteria for the study is that patients have to be 50 years or older and be positive for both copies of ApoE4 and have mild to moderate dementia. There are a variety of other technical criteria that we evaluate in our workup if they have not already been done (they have to have a PET scan that is positive for amyloid and they have to have certain spinal fluid markers of Alzheimer’s disease) but if someone is an ApoE4/E4 with some cognitive impairment that is not too severe and they are old enough, then we would love to talk with them if they are interested and we can figure out the additional testing if appropriate.
We are still recruiting for this study so I have also copied our study coordinator Haley Bowe who helps with recruitment and initial screening and with logistics. She can provide contact information if you would like to include that in your Facebook posting.
If you would like any additional information, please feel free to reach out to me any time.
Thank you for your interest and we look forward to working with your group."
Her contact info is hab4007@med.cornell.edu for anyone interested!

this is a message I received from Lexeo Therapeutics, who are running a HUMAN clinical trial replacing APOE4 with APOE2.
"Are you (or someone you love) 50 years of age or older, experiencing memory loss due to Alzheimer’s disease, and have 2 copies of the APOE4 gene? You may qualify for a clinical trial, sponsored by LEXEO Therapeutics, that is researching a gene therapy treatment for APOE4/E4. Learn more here: [https://lead-study.com]

Karina52 wrote: ↑Tue Jun 20, 2023 3:54 pm this is a message I received from Lexeo Therapeutics, who are running a HUMAN clinical trial replacing APOE4 with APOE2.
"Are you (or someone you love) 50 years of age or older, experiencing memory loss due to Alzheimer’s disease, and have 2 copies of the APOE4 gene? You may qualify for a clinical trial, sponsored by LEXEO Therapeutics, that is researching a gene therapy treatment for APOE4/E4. Learn more here: [https://lead-study.com]

Hi Karina52,

Thanks for activating discussion about gene-editing as a potential therapy for people with ApoE 4/4. I noticed you posted about reaching out to the researchers at Weill Cornell Medical Center in NYC last December in an earlier conversation on this trial: Gene Therapy Trial for ApoE4 Homozygotes.

For those reading about this for the first time, the trial has been going on for several years now, seeking a total of 15 people. Here's a March 2022 press release

The Phase 1/2 clinical trial is an open-label, dose-ranging study evaluating the safety and tolerability of LX1001 in approximately 15 Alzheimer’s disease patients 50 years of age or older who each have two copies of the APOE4 allele (APOE4 homozygous patients). The trial consists of three dose-ascending cohorts. Secondary endpoints include evaluation of the conversion of the cerebrospinal fluid (CSF) from the APOE4 homozygous profile to an APOE4/E2 profile and CSF biomarkers. This trial is enrolling patients with clinical diagnoses ranging from mild cognitive impairment to mild or moderate dementia. Patients must also have evidence of amyloid plaques and CSF biomarkers consistent with Alzheimer’s disease to be included in the trial.

Phase 1 trials seek evidence that a drug is generally safe and "well-tolerated", in a small number of people. and shows evidence (in this case ) of changing the gene in people with ApoE4/4s to ApoE 2/4. Phase 2 trials typically try out high, medium and low doses of the drug to see which has the most effective while also being safe, which this trial is also doing. People don't pick which dose they get; that is randomly assigned. It's "open-label" which means the patient, the study doctors and the people who do the analysis of results all know that they are receiving the treatment. No one is on a placebo.

I'm sure you and I both look forward to hearing more about this from press releases and conference presentations!

this is a message I received from Lexeo Therapeutics, who are running a HUMAN clinical trial replacing APOE4 with APOE2.
"Are you (or someone you love) 50 years of age or older, experiencing memory loss due to Alzheimer’s disease, and have 2 copies of the APOE4 gene? You may qualify for a clinical trial, sponsored by LEXEO Therapeutics, that is researching a gene therapy treatment for APOE4/E4. Learn more here: [https://lead-study.com]

Thanks for sharing, Karina. We've been recruiting for this trial for some time. I merged your post with the original thread as our members may find it interesting to read some of the clinical trial results that have been shared in this thread. We welcome more recent updates if anyone has them.

Lexeo mentioned an interest in doing a webinar for the APOE4 community to learn more about the gene therapy.
Is this something of interest?

Hi Karina. I think this is a great idea!

Lexeo mentioned an interest in doing a webinar for the APOE4 community to learn more about the gene therapy.
Is this something of interest?

I think it's a great idea too, especially if they're willing to share some preliminary data. Please have your contact reach out to juliegee@apoe4.info so we can set it up.

Great idea. The Trial is still open, accepting new participants, so where is there a better source of candidates than here?