Expert Interview
Should investors be encouraged by the Nuplazid Alzheimer's Disease Psychosis data or questionable the decision to advance into Phase 3?
Ticker(s): ACADI would like to interview a Doctor with experience in the development of Alzheimer's Psychosis treatment options as well as currently seeing a large number of patients with the disease. Not sure if doctors typically treat both Alzheimer's and Parkinson's if they are Specialists/Key Opinion Leaders, but someone that has experience with Nuplazid for Parkinson's would be great, provided he or she fits the other criteria.
Please describe your current practice and any relevant experience with the development of Alzheimer's Psychosis treatments
Can you please discuss the similarities between Nuplazid's current indication of Parkinson's Disease Psychosis and the current Phase 2 trial of Alzheimer's Disease Psychosis?
Added By: joe_mccannHow similar are the components of the assessment used in this study, Neuropsychiatric Inventory - Nursing Home Version (NPI-NH), with the endpoints Nuplazid had an impact on in the Parkinson's trials? I know that the company had to work to get the FDA to accept a subgroup of more targeted endpoints in for approval, might that be an issue here?
Added By: joe_mccannThe company has directed investors to look at the 6 week endpoint instead of the 12 week endpoint originally described as the primary endpoint on the Clinical Trials.gov website. Have you heard of a company changing the time period like this? How much of a concern about the drugs effectiveness is this? Could it just be a powering issue since this is a Phase 2 trial?
Added By: joe_mccannHow clinically relevant is the 6 week efficacy difference of Nuplazid vs. Placebo?
A 3.76 point improvement in psychosis at week 6 (for Nuplazid) compared to a 1.93 point improvement for placebo, representing a statistically significant treatment improvement in the NPI-NH Psychosis score (p=0.0451). Baseline mean scores for the pimavanserin and placebo treated groups were 9.52 and 10.00, respectively.
If baseline scores for NPI-NH were 9.52 and 10, what is the best score a patient could get to? How much variability in a 6 week period would these scores have if you took the assessment multiple times?
Added By: joe_mccannDo patients see an immediate impact typically on the Mini-Mental State Examination (MMSE) score when put on an atypical antipsychotic medication? How important to you is it that Nuplazid patients were similar to placebo on this endpoint and did not impair cognition?
Added By: joe_mccannFalls, urinary tract infections and agitation were the most common side effects for Nuplazid patients. How concerning is this to you given the advanced age of the population (86) and what rate give you pause in prescribing this treatment to your patients?
Added By: joe_mccannAre You Interested In These Questions?
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