FORUM Pharmaceuticals Inc., a biopharmaceutical company singularly focused on the development and delivery of innovative medicines to treat serious brain diseases, today announced the completion of patient enrollment in its two pivotal Phase 3 clinical trials investigating the use of encenicline to treat cognitive impairment in schizophrenia.
The Phase 3 clinical trial program, known as COGNITIV SZ, is designed to assess the safety and efficacy of encenicline compared to placebo as a pro-cognitive therapy in patients with schizophrenia treated with atypical antipsychotics.
Each of the two 26-week multinational trials enrolled more than 750 patients.
Encenicline is a novel alpha 7 agonist in Phase 3 development by FORUM to treat cognitive impairment in schizophrenia and Alzheimer’s disease.
You can watch/listen to the webcast here on ForumPharma and their new medication. You have to register first - you don’t have to use your real name - and enter an email address first. The email address also doesn’t need to be a real email address.
a) Cognitive and negative symptoms are better predictors than positive (psychotic) symptoms.
b) Moreover, we know that cognitivity is influenced by environment.
My question is : What if someone suffering SZ goes around only with other SZ people suffering depressed mood and cognitivity. Won’t this low cognitivity/mood environment consequently lowering his/her cognition and mood? This is about structures where SZ public is not mixed with “healthy” one.
Where did you get this from? Why do you believe this? Can you point to some reputable source for this?
Depression tends to cause more stress, and stress impacts memory and thought processing - so perhaps if you only spend time with depressed people it would be negative - but most people don’t only spend time with depressed people. People with schizophrenia generally are pretty socially limited (don’t socialize much) - and that is also a stressor (lack of social engagement is bad for people’s brains) and is stressful.
The only source about this assertion is about babies and children. Babies who have had fewer cares from their mothers have significant changes in their cognitive potential. It is also a risk factor in schizophrenia. Same thing for children who grow in an well-educated family : they have more chances to succeed in studies. I think that environment has an impact on cognitivity. I believe this affirmation is based on some real facts.
OK - Yes, I agree with this. There is a lot of research that supports this claim.
But - after you are grown (say, age 20 or so) the environment no longer makes much difference on cognition (unless it is very stressful - in which case it does hurt you a lot).
All - I’m saying is that yes, it matters when you are younger. But if you’re participating in this forum you’re probably at the age where environment (unless its really bad) doesn’t matter so much.
Ok- After age 20 the brain is finished and environment should be less impacting.
However, social psychology, studies on group dynamic or mirror neurons indicate that brain is an highly suggestible organ even in adulthood : moods and emotions can easily be transmitted.
The FDA eases up on Forum’s schizophrenia program with Alzheimer’s trials still on hold
Forum Pharmaceuticals has gotten out from under an FDA clinical hold on a Phase III schizophrenia study for its lead drug, but the company’s efforts to develop the treatment for Alzheimer’s disease remain halted.
In September, Forum disclosed that the FDA forced it to halt dosing and recruitment in three ongoing Alzheimer’s studies and one trial in cognitive impairment related to schizophrenia after its drug, encenicline, led to “a small number” of serious gastrointestinal side effects, the company said.
Now the FDA has backed off of the schizophrenia program, allowing Forum to get back to work on a 26-week Phase III extension study in that indication. Two earlier-enrolled Phase III schizophrenia studies were unaffected by the hold and are now nearing completion, the company said. If everything goes according to plan, the data from all three studies will support a later FDA application for encenicline in schizophrenia.
