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
Drug: CHF 5074 1x
Drug: CHF 5074 2x
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Full eligibility criteria for NCT01723670
Ages eligible for Study
45 Years to 64 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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.
All locations for NCT01723670
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Tris trial is registered with FDA with number: NCT01723670. The sponsor of the trial is CERESPIR and it is looking for 0 volunteers for the current phase.
Official trial title: 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
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