LEAD Gene Therapy Trial

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MManningCE
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LEAD Gene Therapy Trial

Post by MManningCE »

The LEAD Trial is a Phase 1, open-label trial that will evaluate an investigational gene therapy for the treatment of APOE4 Homozygote Alzheimer’s Disease.

http://www.LEAD-Study.com

WHAT TO EXPECT FROM THE LEAD TRIAL?

At the beginning of the trial, participants will be asked to sign an Informed Consent Form (ICF)*, after which they will undergo a screening period.

Upon consent and screening, eligible patients will be enrolled in the LEAD trial and will receive the gene therapy during a one-time administration. The gene therapy will be given to enrolled patients by injection using local anesthetic (this procedure will last 2-4 minutes). After the procedure, the visit frequency will be weekly for the first 2 weeks, monthly for the first 3 months, and then semi-annually for up to 1 year for a total of 8 visits, including the day of gene therapy treatment (patients may be eligible to have some of these visits conducted at home). After completing this trial, patients will be eligible to enroll into a long-term follow-up trial for another 4 years.

COVID-19 protocols and precautions will be in place at sites. A study coordinator can discuss the processes with you.

Who is eligible to participate in this trial?

Eligible participants are:
● 50 years or older at the time of signing the Informed Consent Form
● Experiencing mild cognitive impairment due to AD, or mild to moderate dementia due to AD
● Genetically confirmed APOE4 homozygote genotype
● Free from any other significant medical or neurological conditions (examples include but are not limited to heart failure, liver failure, or HIV positive)

There are other eligibility requirements related to the LEAD trial, and only a qualified trial professional can determine if you or a loved one is eligible to participate in the trial.



* Informed consent is the process of providing participants with key information about a clinical trial before they decide whether to accept the offer to take part and continue throughout the trial. The trial team provides an informed consent document that includes details about the trial, such as its purpose, how long it’s expected to last, tests or procedures that will be done as part of the research, and who to contact for further information. The informed consent document also explains risks and potential benefits.
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Lidaz
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Re: LEAD Gene Therapy Trial

Post by Lidaz »

[quote="MManningCE"]The LEAD Trial is a Phase 1, open-label trial that will evaluate an investigational gene therapy for the treatment of APOE4 Homozygote Alzheimer’s Disease.

http://www.LEAD-Study.com

Hi MManningCE, thank you for joining the site and sharing this information.

I would encourage you to explore what the site has to offer for people with ApoE 4/4 and you may find the following helpful.

There is an extensive Wiki encyclopedia section where you can search for particular topics and a useful How-To Guide on using the site.

There are some helpful links on the Welcome Page and a good general resource is the Primer

We are so glad to have you join the community. If you have any questions and can't find it on the site, please don't hesitate to ask! :D

Warm regards,
Lisa
Lidaz
Functional Medicine Certified Health Coach
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