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

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 Patient With Mild Cognitive Impairment

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01602393

Acronym

CT04 POLEP

Enrollment

Registered

2012-05-21

Start date

2012-05-31

Completion date

2013-10-31

Last updated

2014-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Brief summary

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.

Interventions

DRUGCHF 5074 1x

oral tablet, 1x, once a day in the morning for 48 weeks

DRUGCHF 5074 2x

oral tablet, 2x, once a day in the morning for 48 weeks

DRUGCHF 5074 3x

oral tablet, 3x, once a day in the morning for 48 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

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).

Design outcomes

Primary

Measure	Time frame
Determine maximum tolerated dose of CHF 5074 after multiple oral once daily administration to patients with mild cognitive impairment	48 weeks

Countries

Italy, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026