Clinical trial NCT01421056: Evaluation of Safety & Tolerability of Multiple Dose Regimens of CHF 5074 and Exploration of Effects on Potential Markers of Clinical Efficacy in Patients With Mild Cognitive Impairment - Open Label Extension (CT04 OLEP)
Official title: A Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Tolerability of Multiple Dose Regimens of CHF 5074 (200, 400, 600 mg/Day for up to 12 Weeks) and to Explore the Effects on Potential Markers of Clinical Efficacy in Patients With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: Chiesi USA, Inc.
Sponsor class: INDUSTRY
First posted: 2011-08-22
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of ascending oral doses of CHF 5074 after prolonged administration to patients with mild cognitive impairment.


Eligibility 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).

Primary outcomes:
measure: Determine maximum tolerated dose of CHF 5074 after multiple oral once daily administration to patients with mild cognitive impairment
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Eatontown
country: United States
facility: Memory Enhancement Center of America, Inc.
state: New Jersey
city: Monroe Twp
country: United States
facility: Memory Center of New Jersey, Inc.
state: New Jersey
city: Toms River
country: United States
facility: Memory Enhancement Center of NJ, Inc.
state: New Jersey
city: Austin
country: United States
facility: Senior Adults Specialty Research
state: Texas
city: Castellanza
country: Italy
facility: Clinica Santa Maria, Div Neurologia
city: Milano
country: Italy
facility: Osp. Niguarda Ca'Granda, Dip. Di Neuroscienze
Study officials:
affiliation: Memory Enhancement Center of America, Inc.
name: Joel S. Ross, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Osp. Niguarda Ca Granda
name: Gabriella Bottini, Prof.
role: PRINCIPAL_INVESTIGATOR
References: