Evaluation of Safety & Tolerability of Multiple Dose Regimens of CHF 5074
Status: | Completed |
---|---|
Conditions: | Alzheimer Disease, Cognitive Studies |
Therapuetic Areas: | Neurology, Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 79 |
Updated: | 4/21/2016 |
Start Date: | March 2011 |
End Date: | April 2012 |
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.
once per day for up to 12 weeks to patients with mild cognitive impairment.
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).
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