Evaluation of Effects of Multiple Dose Regimens of CHF 5074 on Potential Biomarkers of Neurodegeneration in Subjects With Mild Cognitive Impairment
Phase 2
Withdrawn
- Conditions
- Alzheimer's Disease
- Interventions
- Drug: PlaceboDrug: CHF 5074 1xDrug: CHF 5074 2x
- Registration Number
- NCT01723670
- Lead Sponsor
- CERESPIR
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo placebo, oral tablet, multidose CHF 5074 1x CHF 5074 1x oral tablet, multidose CHF 5074 2x CHF 5074 2x oral tablet, multidose
- Primary Outcome Measures
Name Time Method To determine the effects on change from baseline on brain atrophy pre-dose, Months 6, 12, 18, 24 and Washout
- Secondary Outcome Measures
Name Time Method To determine the presence of other biomarkers of neuronal degeneration Month 24