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Evaluation of Safety & Tolerability of Multiple Dose Regimens of CHF 5074 (CT04)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01303744
Recruitment Status : Completed
First Posted : February 25, 2011
Results First Posted : January 11, 2016
Last Update Posted : January 11, 2016
Sponsor:
Information provided by (Responsible Party):
CERESPIR

Study Description
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Brief Summary:
To evaluate the safety and tolerability of ascending oral doses of CHF 5074 administered once per day for up to 12 weeks to patients with mild cognitive impairment.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: CHF 5074 1x Drug: CHF 5074 2x Drug: CHF 5074 3x Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Tolerability of Multiple Dose Regimens of CHF 5074 and to Explore the Effects in Patients With Mild Cognitive Impairment
Study Start Date : March 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CHF 5074 1x
oral tablet, multidose
 Drug: CHF 5074 1x
oral tablet, 1x, once a day in the morning for 12 weeks
Experimental: CHF 5074 2x
oral tablet, multidose
 Drug: CHF 5074 2x
oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks
Experimental: CHF 5074 3x
oral tablet, multidose
 Drug: CHF 5074 3x
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 4 weeks
Placebo Comparator: Placebo
placebo, oral tablet, multidose
 Drug: Placebo
oral tablet, once a day in the morning for 12 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Differences in ∆sCD40L Levels Between CHF 5074 Doses and Placebo at Any Specific Time Point [ Time Frame: up to 12 weeks ]
    To assess if there were differences in ΔsCD40L levels between CHF 5074 doses and placebo


Secondary Outcome Measures :
  1. Measurement of Trough CHF 5074 Plasma Levels [ Time Frame: Days 85 ]
    evaluate the pharmacokinetics (PK) of CHF 5074 in patients with MCI.

  2. Changes in Plasma ΔTNFα Concentrations [ Time Frame: 29 days ]

Eligibility Criteria
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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
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
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Information from the National Library of Medicine

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): NCT01303744


Locations
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United States, Florida
Comprehensive NeuroScience, Inc.
St. Petersburg, Florida, United States, 33716
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
Clinica Santa Maria, Div Neurologia
Castellanza, Italy
Osp. Maggiore Policlinico, Clin. Neurol
Milano, Italy
Osp. Niguarda Ca'Granda, Dip. Di Neuroscienze
Milano, Italy
Nuovo Osp Civ S. Agostino Estense, Dip di Neuroscienze
Modena, Italy
Sponsors and Collaborators
CERESPIR
Investigators
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Principal Investigator: Joel S. Ross, MD Memory Enhancement Center of America, Inc.
Principal Investigator: Gabriella Bottini, Prof. Osp. Niguarda Ca Granda
More Information
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Responsible Party: CERESPIR
ClinicalTrials.gov Identifier: NCT01303744    
Other Study ID Numbers: CCD-1014-PR-0053
2010-024270-19 ( EudraCT Number )
First Posted: February 25, 2011    Key Record Dates
Results First Posted: January 11, 2016
Last Update Posted: January 11, 2016
Last Verified: December 2015
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Flurbiprofen
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action