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)

Alzheimer's Disease Clinical Trial

Official title:

A Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Tolerability of Multiple Dose Regimens of CHF 5074 (200, 400, 600 mg/Day for up to 12 Weeks) and to Explore the Effects on Potential Markers of Clinical Efficacy in Patients With Mild Cognitive Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01421056
• Other study ID #: CCD-1014-PR-0053 OLEP
• Secondary ID: 2010-024270-19
• Status: Completed
• Phase: Phase 2
• First received: August 5, 2011
• Last updated: January 7, 2014
• Start date: July 2011
• Est. completion date: November 2012

Study information

• Verified date: January 2014
• Source: Chiesi USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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).

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cognitive Dysfunction

Intervention

Drug:
• CHF 5074 1x
oral tablet, 1x, once a day in the morning for 24 weeks
• CHF 5074 2x
oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 20 weeks
• CHF 5074 3x
oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 16 weeks

Locations

Country	Name	City	State
Italy	Clinica Santa Maria, Div Neurologia	Castellanza
Italy	Osp. Niguarda Ca'Granda, Dip. Di Neuroscienze	Milano
United States	Senior Adults Specialty Research	Austin	Texas
United States	Memory Enhancement Center of America, Inc.	Eatontown	New Jersey
United States	Memory Center of New Jersey, Inc.	Monroe Twp	New Jersey
United States	Memory Enhancement Center of NJ, Inc.	Toms River	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi USA

Countries where clinical trial is conducted

United States,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine maximum tolerated dose of CHF 5074 after multiple oral once daily administration to patients with mild cognitive impairment		24 weeks