A Phase 1b, Exploratory, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of SDI-118 in Elderly Male and Female Study Participants With Cognitive Decline

ClinicalTrials.gov · TERMINATED, 2022

5 participants

Abstract

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.

Conditions: Cognitive Decline.

Primary outcome: Number of participants with Adverse Events (AEs); Number of participants with laboratory value abnormalities and/or adverse events (AEs); Number of participants with vital sign abnormalities and/or adverse events (AEs); Number of participants with routine 12 lead electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs); Number of participants with C-SSRS abnormalities and/or Adverse Events (AEs); Number of participants with routine physical examination abnormalities and/or Adverse Events (AEs); Number of participants with Changes in the Cogstate Brief Battery, including abnormalities and/or Adverse Events (AEs); Number of participants with Changes in the Digital Symbol Substitution Test, including abnormalities and/or Adverse Events (AEs); Number of participants with Changes in the Controlled Oral Word Association Test, including abnormalities and/or Adverse Events (AEs); Number of participants with Changes in the Category Fluency Test, including abnormalities and/or Adverse Events (AEs).

Enrollment: 5 participants.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 5 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

Read the paper

• ClinicalTrials.gov
• Publisher page

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