Generation Study 2

[Julie G]

Researchers from the Banner Alzheimer’s Institute (BAI), Novartis, and Amgen recently announced the launch of a trial. The new study, known as the Alzheimer’s Prevention Initiative (API) Generation Study 2, will involve more than 2,000 cognitively healthy volunteers, ages 60 to 75, who are at high risk of developing symptoms of Alzheimer’s because of their age and because they carry either one or two copies of the e4 type of the apolipoprotein E (APOE) gene, the major genetic risk factor for late-onset Alzheimer’s disease. Eligible participants will be randomized to receive one of two doses of the investigational anti-amyloid compound CNP520 (15 mg or 50 mg), co-developed by Novartis Pharmaceutical Corporation and biotechnology company Amgen, or a placebo.


This new study is part of a research effort known as the API Generation Program. The first trial, Generation Study 1, is examining whether two investigational anti-amyloid compounds – CAD106, an active immunotherapy, and CNP520 – can prevent or delay the emergence of symptoms of Alzheimer’s among higher-risk cognitively healthy older adults who have two copies of the e4 type of the APOE gene. Generation Study 1, which will involve more than 1,300 cognitively healthy volunteers who are age 60 to 75, began enrolling participants in late 2015.

If you are interested in attending a Generation Program webinar in 2018, please let us know in this thread and we will work with scientists from BAI to organize one.

To qualify for the Generation Program 2, you need to meet the following requirements:
•             60 to 75 years of age
•             Normal memory and thinking ability
•             1 or 2 copies of the APOE e4 allele
•             Have a study partner willing to attend necessary study visits

Enrollment in Generation Study 1 and Generation Study 2 is expected to be complete in 2019. Find out more about becoming a participant at GenerationProgram.com or by calling 1-866-244-8907.

[NF52]

Julie G,
Many thanks for posting this information! I would certainly support offering a webinar on this site; it does not serve as an endorsement, merely the same kind of information that is offered about many other issues.

Members and visitors to this forum are very likely to be either ApoE 3/4, 4/4 or 2/4 and those who are 60-75 may be interested in at least meeting with a Study Coordinator and the medical staff of one of the many sites which have signed on for this study. Just to add some more info, below is the Clinical Trials.gov site with an April 2017 update.

https://clinicaltrials.gov/ct2/show/NCT03131453

The screening period is expected to last about 12 weeks. Participants will receive disclosure of their individual test results for APOE genotyping and brain amyloid status. [Emphasis added by NF52]
Treatment duration is variable (event driven trial) for at least 60 months, and up to an expected maximum of 84 months.
Participants will return to the study site every three months for drug dispensing and every six months for safety and efficacy assessments, including neuropsychological scales with input from the study partner. Brain MRI scans will be conducted at month 6 and month 12, and on a yearly basis thereafter.
The Follow-up visit will be scheduled 12 weeks after the end of the Treatment Epoch. An additional CSF and / or PET AD biomarker assessments will be conducted on a voluntary basis at year 2 and 5.

As you noted, this study will assign people to one of two doses: CNP 520 15mg or CNP 520 50 mg. Because of the need for a control group, about 62% of participants will be blindly assigned (not by anyone at any study site) to the actual drug; the other 38% will be taking a placebo that looks the same.
For anyone considering this study, please know that you won't be asked to make a commitment until you have had as much time as you need to get verbal and written information and ask questions of the study site staff, review a detailed, helpfully-written-in-plain-English-language (!) consent form, take a brief cognitive screening test and meet with the study personnel with your "study partner" (who can be a spouse, partner or close friend). Only after the screening process will you be asked if you are willing to consent to the study itself. You are never pressured. (I declined the voluntary spinal tap, and the voluntary glucose PET scan.) You never lose the ability to say "I don't want to start" or "I have to stop." Your participation will ALWAYS be appreciated by staff who are assigned to this specific study.
Since I am currently taking either a placebo or CNP520 50 mg. as part of the Generations I study, I can say taking a pill once a day (with or without food, at roughly the same time of my choosing) is very easy. CNP 520 is not like early BACE 1&2 inhibitors that were linked to some weird side effects (like orange-y skin--hmmm). Only 14% of participants in an earlier, short-term Stage 1 safety trial of CNP 520 reported some itching of the skin, and in only one case was that considered "severe". , . Although it can seem like a flurry of visits for the screening, once on the drug, return visits are scheduled for only 4 times a year. Flossing is more difficult than taking this pill!
If any of you want to reach out to people on CNP520, you can post a reply, or message me, "mardi" or " p45va". "lol" is also on Generations I and has been taking CAD 106, an amyloid immunotherapy drug, or placebo for a year.

Whatever the results of these studies, we are the ones who can achieve a definitive answer to the BACE 1 hypothesis.