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)
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|ClinicalTrials.gov Identifier: NCT01602393|
Recruitment Status : Completed
First Posted : May 21, 2012
Last Update Posted : February 6, 2014
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|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: CHF 5074 1x Drug: CHF 5074 2x Drug: CHF 5074 3x||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
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
- Determine maximum tolerated dose of CHF 5074 after multiple oral once daily administration to patients with mild cognitive impairment [ Time Frame: 48 weeks ]
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|Ages Eligible for Study:||18 Years to 79 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01602393
|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|
|Osp. Niguarda Ca'Granda, Dip. Di Neuroscienze|
|Principal Investigator:||Joel S Ross, MD||Memory Enhancement Center of America, Inc.|
|Principal Investigator:||Gabriella Bottini, Prof.||Osp. Niguarda Ca Granda|
|Responsible Party:||Chiesi Farmaceutici S.p.A.|
|Other Study ID Numbers:||
2010-024270-19 ( EudraCT Number )
|First Posted:||May 21, 2012 Key Record Dates|
|Last Update Posted:||February 6, 2014|
|Last Verified:||January 2014|
Central Nervous System Diseases
Nervous System Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Molecular Mechanisms of Pharmacological Action