NCT00422981

Safety, Tolerability and Efficacy Study to Evaluate Subjects With Mild Cognitive Impairment

A Phase 2, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Effect on Cognitive Function of AL-108 After 12 Weeks of Intranasal Administration in Subjects With Mild Cognitive Impairment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Allon Therapeutics · Industry
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to find out if different doses of Investigational Drug are safe, tolerable, and if they have an effect on Mild Cognitive Impairment (MCI).

Detailed description

Pre-Clinical experiments indicate the AL-108 compound has neuroprotective, cognitive protective and neurotrophic properties; therefore, the compound could be tested in a variety of human diseases. Human diseases include Cognitive impairment associated with aging or neurodegenerative diseases such as Alzheimer's Disease. This clinical trial aims at providing the dose rationale as well as safety and tolerability information for AL-108 as evaluated after 12 weeks of intranasal administration in subjects with Mild Cognitive Impairment (MCI). There are currently no drugs approved for the treatment of MCI nor accepted treatment or standard treatment approach.

Conditions

• Mild Cognitive Impairment, So Stated

Interventions

Type	Name	Description
DRUG	AL-108	5 mg QD
DRUG	AL-108	15 mg BID
DRUG	Placebo	Placebo

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2007-01-17
• Last updated: 2012-10-24

Locations

17 sites across 1 country: United States