A random distribution of trattaments, which one Placebo, Multicenter Study to Evaluate the Safety and Tolerability of Multiple Dose Regimens of CHF 5074 drug (200, 400, 600 mg/day for up to 12 Weeks) and to Explore the Effects on blood indicators of Clinical Efficacy in Patients with Mild Cognitive Impairment
- Conditions
- Mild Cognitive ImpairmentMedDRA version: 14.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2010-024270-19-IT
- Lead Sponsor
- CHIESI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 96
1. Patientâ??s written informed consent is obtained prior to any study-related procedures. 2. Patient is younger than 80 years of age. 3. Patient has a diagnosis of amnestic or non-amnestic Mild Cognitive Impairment according to modified Petersen, et al`s criteria. 4. Patient has a Mini-Mental State Examination (MMSE) score higher than 24 at screening. 5. MRI scan of the brain at screening with fluid-attenuation inversion recovery (FLAIR) and T2*-weighted gradient-recalled-echo (GRE) sequences. 6. Patientâ??s informant is available.
Are the trial subjects under 18?
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 46
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
A diagnosis of Alzheimerâ??s disease according to the Diagnostic and Statistical Manual of Mental Disorders 4th Edition Text Revision (DSM-IV-TR) or National Institute of Neurological and Communicative Disorders and Stroke-AD and Related Disorders (NINCDS-ADRDA) criteria. 2. 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. 4. MRI scan at screening showing more than 4 cerebral microhemorrhages (lesions with diameter <= 10 mm), regardless of their anatomical location or diagnostic characterization as `possible` or â??definite`. 5. MRI scan at screening showing single area of superficial siderosis, or evidence of a prior macrohemorrhage (lesion with diameter > 10 mm). 6. A Geriatric Depression Scale (30-point scale) score > 9 at screening. 7. History of stroke. Patients with a history of transient ischemic attack may be enrolled, if occurred at least three months prior to screening. 8. A modified Hachinski ischemic scale score > 4 at screening. 9. Women of childbearing potential. Women of childbearing potential include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. 10. Women who are breastfeeding or pregnant. 11. Women with a positive pregnancy test within 72 hours prior to administration of first dose of study medication. 12. Sexually active fertile men not using effective birth control if their partners are women of childbearing potential. 13. Patient has vitamin B12 or folate deficiency. Patients with a B12 deficiency may participate in the study if they are on stable vitamin B12 replacement for at least three months prior to screening. 14. All skin cancers and any cancer that is being actively treated, as well as a history of cancers that are considered to have a high probability of recurrence (with supporting documentation of this from the treating oncologist, if necessary). 15. Clinically significant abnormal coagulations tests. 16. Unstable cardiovascular (includes uncontrolled hypertension), pulmonary, gastrointestinal or hepatic disease one month prior to screening. 17. Diagnosis of schizophrenia or recurrent mood disorder (including unipolar and bipolar disorders) within 3 years of screening. 18. Current diagnosis of peptic ulcer or gastrointestinal bleeding within the last year and/or chronic inflammatory bowel disease. 19. History of neurosyphilis as indicated by positive fluorescent treponemal antibody absorption (FTA-ABS), or microhemagglutination assay (MHA-TP), or treponema pallidum particle agglutination assay (TPPA) tests. 20. Concomitant use of donepezil at doses > 5 mg/day or other cholinesterase inhibitors (rivastigmine or galantamine) at any dose. 21. Concomitant use of memantine at doses > 20 mg/day. 22. Concomitant use of psychoactive drugs (sedatives, hypnotics, etc.). Stable doses of sedatives for conditions such as mild to moderate anxiety or insomnia may be permitted if they have been stable for at least 30 days prior to randomization.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety and tolerability of ascending oral doses (200, 400, or 600 mg/day) of CHF 5074 administered once per day for up to 12 weeks to patients with mild cognitive impairment;Secondary Objective: The secondary objective of this study is to evaluate the pharmacokinetics of CHF 5074 in patients with mild cognitive impairment.;Primary end point(s): The primary endpoint of the study is to determine the maximum tolerated dose (MTD) of CHF 5074 after multiple oral once-daily administrations (up to 12 weeks) to patients with mild cognitive impairment. The MTD of CHF 5074 is defined as the highest dose of the drug that does not, in the opinion of the Data Safety and Monitoring Board (DSMB), cause an intolerable adverse event that is related or possibly related to CHF 5074.;Timepoint(s) of evaluation of this end point: 16 month
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The secondary objective of this study is to evaluate the pharmacokinetics of CHF 5074 in patients with mild cognitive impairment;Timepoint(s) of evaluation of this end point: 16 month