Evaluation of Safety & Tolerability of Multiple Dose Regimens of CHF 5074 and Exploration of Effects on Potential Markers of Clinical Efficacy in Patients With Mild Cognitive Impairment - Open Label Extension (CT04 OLEP)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Chiesi Farmaceutici S.p.A.
Age
18–79
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of amnestic or non-amnestic Mild Cognitive Impairment.
Mini-Mental State Examination score higher than 24 at screening.
MRI scan of the brain at screening with fluid-attenuation inversion recovery (FLAIR) and T2\*-weighted gradient-recalled-echo (GRE) sequences.
You may not be if
Diagnosis of Alzheimer's disease according to the (DSM-IV-TR) or NINCDS-ADRDA criteria.
Any medical condition that could explain the patients cognitive deficits.
CT or MRI brain imaging results obtained within 12 months prior to baseline showing evidence of infection, infarction, or focal lesions of clinical significance
MRI scan at screening showing more than 4 cerebral microhemorrhages (lesions with diameter ≤ 10 mm).
Geriatric Depression Scale (30-point scale) score \> 9 at screening.
History of stroke.
Modified Hachinski ischemic scale score \> 4 at screening.
Women of childbearing potential.
Vitamin B12 or folate deficiency.
Diagnosis of schizophrenia or recurrent mood disorder (including unipolar and bipolar disorders) within 3 years of screening.
Current diagnosis of peptic ulcer or gastrointestinal bleeding within the last year and/or chronic inflammatory bowel disease.
Concomitant use of donepezil at doses \> 5 mg/day or other cholinesterase inhibitors (rivastigmine or galantamine) at any dose.
Concomitant use of memantine at dose \> 20 mg/day.
Concomitant use of psychoactive drugs (sedatives, hypnotics, etc).
Clareo Health | Evaluation of Safety & Tolerability of Multiple Dose Regimens of CHF 5074 and Exploration of Effects on Potential Markers of Clinical Efficacy in Patients With Mild Cognitive Impairment - Open Label Extension (CT04 OLEP)
