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 is ongoing, but not recruiting participants.
Sponsor:
Chiesi Pharmaceuticals Inc.
Information provided by (Responsible Party):
Chiesi Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01602393
First received: May 17, 2012
Last updated: February 8, 2013
Last verified: February 2013
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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 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 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
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: | February 8, 2013 |
| 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 16, 2013