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 - Prolonged Open Label Extension Phase (CT04 POLEP)

Chiesi

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: CHF 5074 2x; Drug: CHF 5074 1x; Drug: CHF 5074 3x

Study type: Interventional

Funder types: Industry

Identifiers

NCT01602393

CCD-1014-PR-0053 POLEP

2010-024270-19 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 51 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 3 patient groups

CHF 5074 1x

Experimental group

Description:

oral tablet, multidose

Treatment:

Drug: CHF 5074 1x

CHF 5074 2x

Experimental group

Description:

oral tablet, multidose

Treatment:

Drug: CHF 5074 2x

CHF 5074 3x

Experimental group

Description:

oral tablet, multidose

Treatment:

Drug: CHF 5074 3x