This is a study to evaluate the efficacy and safety of azeliragon in patients with mild Alzheimer's disease and impaired glucose tolerance. Patients will receive either azeliragon or placebo with a patient's participation lasting approximately 9 months (in Part 1) or 21 months (in Part 2).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
43
Azeliragon 5 mg capsule administered orally, once daily
Matching placebo capsule administered orally, once daily
Part 1 : Change From Baseline in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog14) at Month 6
The Alzheimer's Disease Assessment Scale - Cognitive Subscale 14 Item (ADAS-cog14) scoring range is from 0 to 90, with higher scores indicating greater cognitive impairment
Time frame: Baseline to Month 6
Part 1: Change From Baseline in the Amsterdam-Instrumental Activities of Daily Living (Amsterdam-IADL) at Month 6
The Amsterdam-Instrumental Activities of Daily Living score is calculated from a questionnaire consisting of 70 items in seven categories using an item response theory method of scoring. Scores range from 20 to 80 where lower scores indicate greater functional impairment.
Time frame: Baseline to Month 6
Part 1: Change From Baseline in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-sb) at Month 6
Clinical Dementia Rating - Sum of box (CDR-sb) scores range from 0 to 18 with higher scores indicating greater cognitive impairment.
Time frame: Baseline to Month 6
Part 1: Change From Baseline in the Functional Activities Questionnaire (FAQ) at Month 6
The total FAQ score ranges from 0 to 30, with higher scores indicating greater functional loss.
Time frame: Baseline to Month 6
Mean Change From Baseline in the Mini Mental State Exam (MMSE) at Month 6.
The MMSE scale range is 0 to 30 with lower scores indicating greater cognitive impairment.
Time frame: Baseline to Month 6
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