Evaluation of Effects of Multiple Dose Regimens of CHF 5074 on Potential Biomarkers of Neurodegeneration in Subjects With Mild Cognitive Impairment

A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Effects of Multiple Dose Regimens of CHF 5074 for up to 2 Years on Potential Biomarkers of Neurodegeneration in Subjects With Mild Cognitive Impairment

To evaluate the effects of multiple dose regimens of CHF 5074 administered once per day up to 2 years on potential biomarkers of neurodegeneration in subjects with mild cognitive impairment.

Inclusion Criteria:

• One or two Ɛ4 alleles of the apolipoprotein E (APOE) gene.
• Diagnosis of amnestic Mild Cognitive Impairment.
• Mini-Mental State Examination score higher than 24 at screening.

Exclusion Criteria:

• Diagnosis of Alzheimer's disease.
• Any medical condition that could explain the subject's cognitive deficits.
• MRI scans having evidence of pre-specified brain abnormalities.
• History of stroke.
• Vitamin B12 or folate deficiency.
• Skin cancers and any cancer that is being actively treated.
• Diagnosis of schizophrenia or recurrent mood disorder.
• Abnormal kidney function.
• Concomitant use of any study prohibitive medication.