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

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

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: CHF 5074 1x; Drug: CHF 5074 2x; Drug: CHF 5074 3x; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Castellanza, Italy
    • Clinica Santa Maria, Div Neurologia
  • Milano, Italy
    • Osp. Niguarda Ca'Granda, Dip. Di Neuroscienze
  • Milano, Italy
    • Osp. Maggiore Policlinico, Clin. Neurol
  • Modena, Italy
    • Nuovo Osp Civ S. Agostino Estense, Dip di Neuroscienze
• United States
  • Florida
    • St. Petersburg, Florida, United States, 33716
      • Comprehensive NeuroScience, Inc.
  • New Jersey
    • Eatontown, New Jersey, United States, 07724
      • Memory Enhancement Center of America, Inc.
    • Monroe Twp, New Jersey, United States, 08831
      • Memory Center of New Jersey, Inc.
    • Toms River, New Jersey, United States, 08755
      • Memory Enhancement Center of NJ, Inc.
  • Texas
    • Austin, Texas, United States, 78757
      • Senior Adults Specialty Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in ∆sCD40L Levels Between CHF 5074 Doses and Placebo at Any Specific Time Point	To assess if there were differences in ΔsCD40L levels between CHF 5074 doses and placebo	up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Trough CHF 5074 Plasma Levels	evaluate the pharmacokinetics (PK) of CHF 5074 in patients with MCI.	Days 85
Changes in Plasma ΔTNFα Concentrations		29 days

Collaborators and Investigators

• Sponsor: CERESPIR

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (ACTUAL): April 1, 2012
• Study Completion (ACTUAL): April 1, 2012

Study Registration Dates

• First Submitted: February 23, 2011
• First Submitted That Met QC Criteria: February 23, 2011
• First Posted (ESTIMATE): February 25, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): January 11, 2016
• Last Update Submitted That Met QC Criteria: December 2, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Flurbiprofen
• Other Study ID Numbers: CCD-1014-PR-0053; 2010-024270-19 (EudraCT Number)