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

• Status: Withdrawn
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CERESPIR
• Treatments: Flurbiprofen

Criteria

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.