Bunetanetap Trial participants questions

[NextStage]

I just started in the Buntanetap Trial with my baseline visit/first receiving the drug on Tuesday April 18th. I have a few questions for other Butanetap Trial participants.

[Hidden]

how do you know you received the drug and not a placebo?

[NextStage in reply to Hidden]

I don't know

[Hidden in reply to NextStage]

You wrote 'the drug' so I was under impression you somehow knew.

[Bolt_Upright]

Good luck!

[NextStage in reply to Bolt_Upright]

Thanks Dave❤️

[park_bear]

The pharmacology of buntanetap is not the same as that of levodopa. I'm quite certain that with regard to dosage instructions Annovis knows what they are doing. Just follow those instructions and do not overthink the matter. As to the mannitol I doubt that the small amount included in the capsule has any biological effect.

[NextStage in reply to park_bear]

I understand that Buntanetap is inhibiting the translation process which creates the alpha-synuclein protein from being formed, which is altogether different from levadopa. However, I didn't know if it was also a protein. I was not so much thinking that Annovis didn't know what they are doing, but that possibly this direction had gotten slightly modified in being communicated to me, ala the "telephone" game I used to play as a kid.

[park_bear in reply to NextStage]

Strictly speaking levodopa is an amino acid rather than a protein. Buntanetap is neither. I doubt that the trial site would screw up something as basic as dosing instructions, To remove all doubt you could confirm with the company directly.

[SanMateoPD]

I think it's great how analytical you are being in your investigation. Good luck!

[1953bullard]

I was told I could take anytime. I take before breakfast

[NextStage in reply to 1953bullard]

Interesting that you got different (looser) instructions. If you hold your capsule up in direct sunlight, how full is your capsule?

[1953bullard in reply to NextStage]

can’t tell, it’s totally opaque

[Boscoejean]

Buntanetap, a Novel Translational Inhibitor of Multiple Neurotoxic Proteins

The drug candidate is the enantiomer of phenserine. It is administered through oral route. It acts by targeting amyloid precursor protein (APP), tau and alpha-synuclein. It was also under development for the treatment of Huntington's disease and traumatic brain injury.

pharmaceutical-technology.c....

[Gallowglass]

sounds risky to me.

[Pixelpixie]

I’ve been taking it for 3 weeks. I believe they want a fasting blood test to get an accurate read of drug metabolism. I was told to take pill just before breakfast. First visit w med was a fasting blood test, pill, another blood test, then breakfast. Of course I may be on a placebo. No way to know

[NextStage in reply to Pixelpixie]

I also had 3 separate blood draws in the baseline visit, with the first being fasting. However, in my case I was told to eat a little something after the first blood draw before baseline UPDRS testing, etc, before I got the drug. Then it was optional whether or not I had some food after taking drug, while waiting for third blood draw that was 1.5 hours after taking medicine.

If you hold your capsule up in direct sunlight, how full is your capsule?

[Joemartin in reply to NextStage]

How does one apply for trial?

[NextStage in reply to Joemartin]

Unfortunately, I believe that this study is already full. They wanted 450 participants. A few weeks ago they already had 330 started and another 150 that were screened, and so they were determining which sites would get the drug and trying to determine how many people they expected to drop out.

[Ctime]

Next,

I have been taking pills as part of the Buntanetap trail for several months. I do not put out much information because placebo bias as well as nocebo effects are real! The protocol is the protocol and getting media one way or the other could have a very real effect on results.

However, I think this forum is a great place to get support for the fears, concerns and practical issues related to being on any clinical trial. When I am honest with myself I am way more emotionally invested than I want to admit. It is hard to compartmentalize "mights" and "maybes" and get on with daily living.

Briefly: my capsules are about the same fill as yours so probably normal.

I was told to take them in the morning but I don't remember anything specific relative to meals. I would reach out to your trial coordinator if you have specific concerns about timing.

The most robust self monitoring you could do would be to get an Apple Watch and one of the new FDA approved apps but this would almost certainly bias your results. Particularly as you don't now have baseline data, you could easily believe that your data was going one way or the other. I believe that trials with wearables do not release the monitoring data until the trial is unblinded if ever.

I will say that nothing in my experience makes me concerned about this drug. My experience with 5 clinical trials has been largely positive and I would encourage others to get involved if they can.

[Gioc]

5 clinical trial? Congratulations and thank you!🙏

[shoreforsure]

I started early March. Yes I received the same instructions, take 1 pill right before food. I don't have a specific test like your typing test. A test like your typing would be different each day for me. I agree the standard tests are too subjective. I am beginning to believe I am on the placebo as I don't feel any changes yet. Maybe I am too impatient. Good Luck!

[SanMateoPD]

I've received communication from Annovis that they are not actually looking for more participants, despite last month talking to them and having arranged an interview to join their trial of buntanetap.