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)

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and tolerability of ascending oral doses of CHF 5074 after prolonged administration to patients with mild cognitive impairment.

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

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.; Chiesi Pharmaceuticals Inc.
• Treatments: Flurbiprofen

Criteria

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).