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 (CT04 POLEP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01602393
First received: May 17, 2012
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 Patient With Mild Cognitive Impairment

Resource links provided by NLM:


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: 48 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 51
Study Start Date: May 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (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 48 weeks
Experimental: CHF 5074 2x
oral tablet, multidose
Drug: CHF 5074 2x
oral tablet, 2x, once a day in the morning for 48 weeks
Experimental: CHF 5074 3x
oral tablet, multidose
Drug: CHF 5074 3x
oral tablet, 3x, once a day in the morning for 48 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01602393

Locations
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
Osp. Niguarda Ca'Granda, Dip. Di Neuroscienze
Milano, 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: NCT01602393     History of Changes
Other Study ID Numbers: CCD-1014-PR-0053 POLEP, 2010-024270-19
Study First Received: May 17, 2012
Last Updated: January 7, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Italy: Ethics Committee

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Mild Cognitive Impairment
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on October 20, 2014