ADP
Most common initial sign of AD
memory impairment
Age range for eligibility at time of informed consent
55-90 years old
Visit randomization occurs
What is baseline?
True or False: Sites can request access to Atreo (IRT)
FALSE - CRA must add site contact information to the "Site Contact and Vendor Information" tracker
What is the primary endpoint?
The change from Baseline to Week 7 in the NPI-C H+D score
Psychotic symptoms experienced by patients with ADP
What are delusions and/or hallucinations?
What is a urological exclusion for male participants?
History of prostate cancer
Visits the NPI-C is administered
All, except for follow up
Reduce placebo response by excluding individuals who see improvement from non-drug approach
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%?
Exclusionary dementias
Lewy Body Disease
Frontotemporal Dementia
Primary Progressive Aphasia
Visits the MMSE is administered
What is screening, baseline, and week 7
What is the KardiaMobile device used for?
At home ECG - specifically for ECG required within 3 days of starting higher dose
Reporting timeline for an SAE
What is 24 hours?
The binding location targeted by ML-007C-MA
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
True or False: Site staff is unable to check KardiaMobile ECGs until participant returns to site
What is the purpose of the NPI?
It is used to assess neuropsychiatric symptoms in neurodegenerative disorders
Type of medication used as an off-label treatment for ADP
Dopaminergic antipsychotics
What is an exception to the oncology exclusion?
Non-melanoma skin cancer
Visit for optional blood testing
What is baseline
Who at MapLight assigns IRT access?
Meagan and Sonika
Donanemab and Bupropion are examples of this
What is a prohibited medication?