This is a multi-center, double-blind, randomized, placebo-controlled study to determine the safety, tolerability, and pharmacodynamics of SDI-118 in a once daily (QD) dosing regimen on elderly male and female study participants with cognitive decline at screening.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
5
SDI-118 Powder in Capsules (PiC) are presented as Drug Substance in white, size 3, hydroxypropylmethylcellulose (HPMC) capsules. No excipients are added.
The Matching Placebo for SDI-118 PiC is equivalent dose of mannitol (an inert excipient) in white, size 3, hydroxypropylmethylcellulose (HPMC) capsules.
University Hospital Frankfurt
Frankfurt am Main, Germany
St Pancras Clinical Research
London, United Kingdom
Number of participants with Adverse Events (AEs)
Adverse events (AEs) will be coded using medical dictionary for regulatory activities (MedDRA). An AE is any untoward medical occurrence in a participant administered a study drug and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical product whether or not considered related to the medical product. An AE is considered "serious" if, in the view of either the investigator or sponsor, the event: results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires hospitalization or prolongation to hospitalization, or other medically important event.
Time frame: 17 days
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant laboratory values (hematology/chemistry/urinalysis).
Time frame: 17 days
Number of participants with vital sign abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant vital sign values.
Time frame: 17 days
Number of participants with routine 12 lead electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant ECG values.
Time frame: 17 days
Number of participants with C-SSRS abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant changes in C-SSRS values.
Time frame: 17 days
Number of participants with routine physical examination abnormalities and/or Adverse Events (AEs)
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Number of participants with potentially clinically significant changes in physical examination.
Time frame: 17 days
Number of participants with Changes in the Cogstate Brief Battery, including abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant changes in the Cogstate Brief Battery values.
Time frame: 17 days
Number of participants with Changes in the Digital Symbol Substitution Test, including abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant changes in the DSST values.
Time frame: 17 days
Number of participants with Changes in the Controlled Oral Word Association Test, including abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant changes in the COWAT values.
Time frame: 17 days
Number of participants with Changes in the Category Fluency Test, including abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant changes in the CFT values.
Time frame: 17 days
Changes in Blood Oxygen Level Dependent (BOLD) signal
As measured by changes in deoxyhemoglobin levels driven by localized changes in brain blood flow and blood oxygenation in brain networks associated with executive function (working memory), including the prefrontal cortex, the hippocampus, and the associated limbic networks, during performance of the N-Back Tasks
Time frame: 17 days
Performance measures associated with executive function (working memory) during the N-Back Tasks
As measured by both response accuracy and response latency between cue stimulus and detection of this cue in the presented trial stimuli
Time frame: 17 days