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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
96
oral tablet, 1x, once a day in the morning for 12 weeks
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
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
Comprehensive NeuroScience, Inc.
St. Petersburg, Florida, United States
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States
Memory Center of New Jersey, Inc.
Monroe Twp, New Jersey, United States
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
Time frame: up to 12 weeks
Measurement of Trough CHF 5074 Plasma Levels
evaluate the pharmacokinetics (PK) of CHF 5074 in patients with MCI.
Time frame: Days 85
Changes in Plasma ΔTNFα Concentrations
Time frame: 29 days
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oral tablet, once a day in the morning for 12 weeks
Memory Enhancement Center of NJ, Inc.
Toms River, New Jersey, United States
Senior Adults Specialty Research
Austin, Texas, United States
Clinica Santa Maria, Div Neurologia
Castellanza, Italy
Osp. Maggiore Policlinico, Clin. Neurol
Milan, Italy
Osp. Niguarda Ca'Granda, Dip. Di Neuroscienze
Milan, Italy
Nuovo Osp Civ S. Agostino Estense, Dip di Neuroscienze
Modena, Italy