The main purpose of this study is to evaluate the safety, tolerability, and effect on biomarkers of disease pathophysiology and pathology, pharmacokinetics (PK), and preliminary effects on measures of clinical efficacy of multiple doses of ASN51 in adult participants with early Alzheimer's disease (AD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
123
K2 Medical Research
Clermont, Florida, United States
K2 Medical Research - The Villages
Lady Lake, Florida, United States
K2 Medical Research
Maitland, Florida, United States
Alzheimer's Treatment and Research Center
Stuart, Florida, United States
Number of Participants With Adverse Events (AEs)
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Time frame: From first dose up to end of the study up to Week 28
Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS is used to assess the suicidality of participants and assessment includes "yes" or "no" responses for 5 questions, each related to suicidal ideation and suicidal behavior. Numeric ratings are provided for suicidal ideation (score ranges from 1 to 5, where higher scores indicate more suicidal ideation) and suicidal behavior (score ranges from 0 to 4 where higher total scores indicate more suicidal behavior).
Time frame: Baseline up to Week 28
Change From Baseline in Cerebrospinal Fluid (CSF) Plasma Tau Phosphorylated at Threonine-217 (pTau217) Through Week 24
Time frame: Baseline through Week 24
Change From Baseline in CSF Total Tau Protein Through Week 24
Time frame: Baseline through Week 24
Change From Baseline in Plasma pTau217 Through Week 24
Time frame: Baseline through Week 24
Change From Baseline in MK-6240 Tau Positron Emission Tomography (PET) Signal Through Week 24
Time frame: Baseline through Week 24
Trough Plasma Concentration (Cmin) of ASN51 in Plasma at Steady State
Time frame: Pre-dose on Day 1 and at multiple time points post-dose up to Week 24
Maximum Plasma Concentration (Cmax) of ASN51 at Steady State
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Alzheimer's Treatment and Research Center
Wellington, Florida, United States
Columbus Memory Center, LLC
Columbus, Georgia, United States
Re:Cognition Health
Fairfax, Virginia, United States
Time frame: Pre-dose on Day 1 and at multiple time points post-dose up to Week 24