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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 - Open Label Extension (CT04 OLEP)

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CHF 5074 1x
CHF 5074 2x
CHF 5074 3x
Sponsored by
Chiesi Farmaceutici S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Memory Enhancement Center of America, Inc.
  • Memory Center of New Jersey, Inc.
  • Memory Enhancement Center of NJ, Inc.
  • Senior Adults Specialty Research
  • Clinica Santa Maria, Div Neurologia
  • Osp. Niguarda Ca'Granda, Dip. Di Neuroscienze

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

CHF 5074 1x

CHF 5074 2x

CHF 5074 3x

Arm Description

oral tablet, multidose

oral tablet, multidose

oral tablet, multidose

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 5, 2011
Last Updated
January 7, 2014
Sponsor
Chiesi Farmaceutici S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01421056
Brief Title
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)
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiesi Farmaceutici S.p.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHF 5074 1x
Arm Type
Experimental
Arm Description
oral tablet, multidose
Arm Title
CHF 5074 2x
Arm Type
Experimental
Arm Description
oral tablet, multidose
Arm Title
CHF 5074 3x
Arm Type
Experimental
Arm Description
oral tablet, multidose
Intervention Type
Drug
Intervention Name(s)
CHF 5074 1x
Intervention Description
oral tablet, 1x, once a day in the morning for 24 weeks
Intervention Type
Drug
Intervention Name(s)
CHF 5074 2x
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
CHF 5074 3x
Intervention Description
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
Primary Outcome Measure Information:
Title
Determine maximum tolerated dose of CHF 5074 after multiple oral once daily administration to patients with mild cognitive impairment
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel S. Ross, MD
Organizational Affiliation
Memory Enhancement Center of America, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gabriella Bottini, Prof.
Organizational Affiliation
Osp. Niguarda Ca Granda
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memory Enhancement Center of America, Inc.
City
Eatontown
State/Province
New Jersey
ZIP/Postal Code
07724
Country
United States
Facility Name
Memory Center of New Jersey, Inc.
City
Monroe Twp
State/Province
New Jersey
ZIP/Postal Code
08831
Country
United States
Facility Name
Memory Enhancement Center of NJ, Inc.
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Senior Adults Specialty Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
Clinica Santa Maria, Div Neurologia
City
Castellanza
Country
Italy
Facility Name
Osp. Niguarda Ca'Granda, Dip. Di Neuroscienze
City
Milano
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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)

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