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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

May 17, 2012
January 7, 2014
May 2012
October 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01602393 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: CHF 5074 1x
    oral tablet, 1x, once a day in the morning for 48 weeks
  • Drug: CHF 5074 2x
    oral tablet, 2x, once a day in the morning for 48 weeks
  • Drug: CHF 5074 3x
    oral tablet, 3x, once a day in the morning for 48 weeks
  • Experimental: CHF 5074 1x
    oral tablet, multidose
    Intervention: Drug: CHF 5074 1x
  • Experimental: CHF 5074 2x
    oral tablet, multidose
    Intervention: Drug: CHF 5074 2x
  • Experimental: CHF 5074 3x
    oral tablet, multidose
    Intervention: Drug: CHF 5074 3x
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
October 2013
October 2013   (final data collection date for primary outcome measure)

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).
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Italy
 
NCT01602393
CCD-1014-PR-0053 POLEP, 2010-024270-19
No
Chiesi Pharmaceuticals Inc.
Chiesi Pharmaceuticals Inc.
Not Provided
Principal Investigator: Joel S Ross, MD Memory Enhancement Center of America, Inc.
Principal Investigator: Gabriella Bottini, Prof. Osp. Niguarda Ca Granda
Chiesi Pharmaceuticals Inc.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP