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

Phase 2

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: CHF 5074 2x; Drug: CHF 5074 1x; Drug: CHF 5074 3x

• Registration Number: NCT01602393
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-17
• Study First Submitted QC: 2012-05-17
• Study First Posted: 2012-05-21
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-01
• Disposition First Submitted: 2014-01-07
• Disposition First Submitted QC: 2014-01-07
• Last Update Submitted: 2014-01-07
• Disposition First Posted: 2014-02-06
• Last Update Posted: 2014-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHF 5074 2x	CHF 5074 2x	oral tablet, multidose
CHF 5074 1x	CHF 5074 1x	oral tablet, multidose
CHF 5074 3x	CHF 5074 3x	oral tablet, multidose

Primary Outcome Measures

Name	Time	Method
Determine maximum tolerated dose of CHF 5074 after multiple oral once daily administration to patients with mild cognitive impairment	48 weeks

Trial Locations

Locations (5)

Memory Enhancement Center of NJ, Inc.; 🇺🇸 Toms River, New Jersey, United States

Senior Adults Specialty Research; 🇺🇸 Austin, Texas, United States

Osp. Niguarda Ca'Granda, Dip. Di Neuroscienze; 🇮🇹 Milano, Italy

Memory Center of New Jersey, Inc.; 🇺🇸 Monroe Twp, New Jersey, United States

Memory Enhancement Center of America, Inc.; 🇺🇸 Eatontown, New Jersey, United States