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 - Prolonged Open Label Extension Phase

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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).