NCT03522129

Study to Evaluate the Effect of CT1812 Treatment on Amyloid Beta Oligomer Displacement Into CSF in Subjects With Mild to Moderate Alzheimer's Disease

A Pilot Study to Evaluate the Effect of CT1812 Treatment on Amyloid Beta Oligomer Displacement Into CSF in Subjects With Mild to Moderate Alzheimer's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Cognition Therapeutics · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, Phase 1b, randomized, double-blind, placebo-controlled parallel-group trial in adults with mild to moderate AD.

Detailed description

This is a multi-center, Phase 1b, randomized, double-blind, placebo-controlled parallel-group trial in adults with mild to moderate AD. The primary endpoint is the change from the baseline CSF Amyloid beta oligomer concentration after dosing with CT1812 versus placebo. The change from baseline will be measured through a number of exploratory endpoints as indicated below. For each subject, the baseline CSF oligomer concentration will be computed as the average of the measurements from hours -4, -3, -2 and -1 and 0.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	CT1812	Active Study Drug
DRUG	Placebo	Non-active study drug

Timeline

• Start date: 2018-05-30
• Primary completion: 2019-02-06
• Completion: 2019-02-06
• First posted: 2018-05-11
• Last updated: 2022-01-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study