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 - Full Text View

Purpose

To evaluate the safety and tolerability of ascending oral doses of CHF 5074 administered once per day for up to 12 weeks to patients with mild cognitive impairment.

Condition	Intervention	Phase
Alzheimer's Disease	Drug: CHF 5074 1x Drug: CHF 5074 2x Drug: CHF 5074 3x Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Mild Cognitive Impairment

U.S. FDA Resources

Further study details as provided by Chiesi Pharmaceuticals Inc.:

Primary Outcome Measures:

Determine maximum tolerated dose of CHF 5074 after multiple oral once daily administration to patients with mild cognitive impairment [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Measurement of trough CHF 5074 plasma levels [ Time Frame: Days 29, 57 and 85 ] [ Designated as safety issue: No ]

Enrollment:	96
Study Start Date:	March 2011
Study Completion Date:	April 2012
Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CHF 5074 1x oral tablet, multidose	Drug: CHF 5074 1x oral tablet, 1x, once a day in the morning for 12 weeks
Experimental: CHF 5074 2x oral tablet, multidose	Drug: 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 8 weeks
Experimental: CHF 5074 3x oral tablet, multidose	Drug: 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 4 weeks
Placebo Comparator: Placebo placebo, oral tablet, multidose	Drug: Placebo oral tablet, once a day in the morning for 12 weeks

Eligibility

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303744

Locations

United States, Florida
Comprehensive NeuroScience, Inc.
St. Petersburg, Florida, United States, 33716
United States, New Jersey
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States, 07724
Memory Center of New Jersey, Inc.
Monroe Twp, New Jersey, United States, 08831
Memory Enhancement Center of NJ, Inc.
Toms River, New Jersey, United States, 08755
United States, Texas
Senior Adults Specialty Research
Austin, Texas, United States, 78757
Italy
Clinica Santa Maria, Div Neurologia
Castellanza, Italy
Osp. Maggiore Policlinico, Clin. Neurol
Milano, Italy
Osp. Niguarda Ca'Granda, Dip. Di Neuroscienze
Milano, Italy
Nuovo Osp Civ S. Agostino Estense, Dip di Neuroscienze
Modena, Italy

Sponsors and Collaborators

Chiesi Pharmaceuticals Inc.

Investigators

Principal Investigator:	Joel S. Ross, MD	Memory Enhancement Center of America, Inc.
Principal Investigator:	Gabriella Bottini, Prof.	Osp. Niguarda Ca Granda

More Information

No publications provided

Responsible Party:	Chiesi Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT01303744 History of Changes
Other Study ID Numbers:	CCD-1014-PR-0053, 2010-024270-19
Study First Received:	February 23, 2011
Last Updated:	August 9, 2012
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board Italy: Ethics Committee

Additional relevant MeSH terms:

Alzheimer Disease
Cognition Disorders
Dementia
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013

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 (CT04)