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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
144
Pivotal Research
Peoria, Arizona, United States
Collaborative Neuroscience Network
Garden Grove, California, United States
Change from baseline to Week 12 on the Composite Memory Variable
Time frame: 12 weeks
Changes in the Composite Memory Variable from baseline to weeks 4, 8, and 16
Time frame: 16 weeks
Changes in test battery individual items from baseline to endpoints (weeks 4, 8, 12, and 16).
Time frame: 16 weeks
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...and 7 more locations