ADP
The approximate amount of people in the US with AD
What is 6 million?
Age range for eligibility at time of informed consent
What is 55-90 years old?
Visit randomization occurs
What is baseline?
PRN
episodic (as needed) use of a medication
The change from Baseline to Week 7 in the NPI-C H+D score
What is the primary endpoint?
Psychotic symptoms experienced by patients with ADP
What are delusions and/or hallucinations?
What is a urological exclusion for male participants?
Visits the NPI-C is administered
All, except for follow up
Developed specifically to assess neuropsychiatric symptoms in neurodegenerative disorders
What is the NPI?
Reduced dose amount for participants who do not tolerate target dose
What is 105/1.5 mg BID
The percentage of AD patients who experience psychotic symptoms (at least ones in their lifetime)
What is 40%?
Required MMSE score at screening
What is 6-26 (inclusive)
Visits the MMSE is administered
What is screening, baseline, and week 7
PK
What is pharmacokinetics
Reporting timeline for an SAE
What is 24 hours?
The binding location targeted by ML-007C-MA
What are the M1 and M4 receptors?
Reasons a female participant would be considered NOT of childbearing potential
Postmenopausal (and confirmed by documented FSH levels) OR surgically sterile
Visits where physical and neurological exam are completed
What is screening and week 7
An SAE that is believed with reasonable probability to be due to the investigational product, but nature is not consistent with the known safety info
What is a SUSAR (Suspected Unexpected Serious Adverse Reaction)?
The study design
randomized, double-blind, placebo-controlled
Dopaminergic antipsychotics are an example of these
What is an off-label treatment for ADP?
Non-melanoma skin cancer
What is an exception to the oncology exclusion?
Visit for optional blood testing
What is baseline
5-HMT
What is 5-hydroxymethyltolterodine?
Donanemab and Bupropion are examples of this
What is a prohibited medication?