This study will investigate the ability of ST101 to improve memory in people with Alzheimer's disease. This study also will examine the safety and tolerability of the drug. This study is evaluating 3 different dose levels of ST101 and placebo. Patients will have a 1 in 4 chance of getting placebo.
Alzheimer's disease (AD) is a progressive and fatal neurological illness. It produces changes in the brain that include loss of cells and accumulation of abnormal protein deposits. Initial symptoms are cognitive, with deficiencies in short-term memory the most common symptom. As the disease progresses so does the severity of cognitive deficiency. Loss of speech and immobility occur in the terminal stages There is no cure for AD and no marketed treatment that modifies the underlying disease process. Available therapies improve some symptoms of AD by increasing brain concentrations of molecules involved in cognition. ST101 differs from marketed therapies in that it has demonstrated two actions in animal research testing. It improves cognition and it also reduces the accumulation of abnormal protein deposits in the brain. These two properties suggest that ST101 may be a promising agent for the treatment of AD. This study is designed as a preliminary dose exploration/proof-of-concept investigation of the ability of ST101 to improve cognition during 12 weeks of administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
168
Unnamed facility
Costa Mesa, California, United States
Unnamed facility
Redlands, California, United States
Unnamed facility
San Diego, California, United States
Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-cog)
Time frame: Baseline, 4 weeks, 8 weeks,12 weeks
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Neuropsychiatric Inventory (NPI)
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Alzheimer's Disease Cooperative Study- Clinical Global Impression (ADCS-CGI)
Time frame: Baseline (severity); 4 weeks, 8 weeks, 12 weeks (change)
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placebo to match ST101 tablets
Unnamed facility
Walnut Creek, California, United States
Unnamed facility
Deerfield Beach, Florida, United States
Unnamed facility
Delray Beach, Florida, United States
Unnamed facility
Orlando, Florida, United States
Unnamed facility
West Palm Beach, Florida, United States
Unnamed facility
Indianapolis, Indiana, United States
Unnamed facility
Shreveport, Louisiana, United States
...and 8 more locations