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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Osp. Niguarda Ca'Granda, Dip. Di Neuroscienze, Milan, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

CHF 5074 1x

Drug

oral tablet, 1x, once a day in the morning for 48 weeks

CHF 5074 2x

Drug

oral tablet, 2x, once a day in the morning for 48 weeks

CHF 5074 3x

Drug

oral tablet, 3x, once a day in the morning for 48 weeks

Primary outcomes

Determine maximum tolerated dose of CHF 5074 after multiple oral once daily administration to patients with mild cognitive impairment

Time frame: 48 weeks

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study 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 Patient With Mild Cognitive Impairment

Acronym: CT04 POLEP

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: May 21, 2012
Registry last updated: Feb 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed