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

CERESPIR

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Conditions

Alzheimer's Disease

Interventions

CHF 5074 1xDRUG

oral tablet, 1x, once a day for 24 months

CHF 5074 2xDRUG

oral tablet, 2x, once a day for 24 months

PlaceboDRUG

oral tablet,once a day for 24 months

Eligibility

Sex: ALLMin age: 45 YearsMax age: 64 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

To determine the effects on change from baseline on brain atrophy

Time frame: pre-dose, Months 6, 12, 18, 24 and Washout

Secondary Outcomes

To determine the presence of other biomarkers of neuronal degeneration

Time frame: Day 1

To determine the presence of other biomarkers of neuronal degeneration

Time frame: Month 24

Data from ClinicalTrials.gov

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