The study will evaluate the safety \& efficacy of AC-1204, a ketogenic compound, administered orally on a daily basis for 6 months. Following the 6 month double-blind phase of the study, subjects may enroll in an optional 6 month open-label extension phase. Efficacy will be evaluated by standard tests of memory and cognition, along with other measurements of activities of daily living and quality of life. Safety will be assessed by frequency of adverse events and changes in laboratory test results. Subjects will be stratified and outcomes will be separately analyzed based on apolipoprotein E4 genotype (APOE4).
Two primary outcome measures will be assessed in APOE4(-) patients: 1. differences from baseline between AC-1204 and placebo groups' ADAS-cog scores at 6 months 2. differences from baseline between AC-1204 and placebo groups' CIBIC+ scores at 6 months Secondary endpoints will include differences between AC-1204 \& placebo groups' scores for these same instruments at 3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
oral, 20 gm, daily x 6 months
oral, 14 gm, daily x 6 months
Meridien Research
St. Petersburg, Florida, United States
Alzheimer's disease assessment scale - cognitive subscale (ADAS-cog)
change from baseline in ADAS-cog scores at 6 months in APOE4(-) patients
Time frame: 6 months
Clinicians Interview Based Impression of Change with Caregiver Input (CIBIC+)
change from baseline in CIBIC+ scores at 6 months in APOE4(-) patients
Time frame: 6 months
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