Evaluation of Effects of Multiple Dose Regimens of CHF 5074 on Potential Biomarkers of Neurodegeneration in Subjects With Mild Cognitive Impairment

A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Effects of Multiple Dose Regimens of CHF 5074 for up to 2 Years on Potential Biomarkers of Neurodegeneration in Subjects With Mild Cognitive Impairment

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01723670

Acronym

CT05

Enrollment

Registered

2012-11-08

Start date

2012-12-31

Completion date

2016-03-31

Last updated

2015-02-10

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

To evaluate the effects of multiple dose regimens of CHF 5074 administered once per day up to 2 years on potential biomarkers of neurodegeneration in subjects with mild cognitive impairment.

Interventions

DRUGCHF 5074 1x

oral tablet, 1x, once a day for 24 months

DRUGCHF 5074 2x

oral tablet, 2x, once a day for 24 months

DRUGPlacebo

oral tablet,once a day for 24 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

45 Years to 64 Years

Healthy volunteers

Inclusion criteria

* One or two Ɛ4 alleles of the apolipoprotein E (APOE) gene. * Diagnosis of amnestic Mild Cognitive Impairment. * Mini-Mental State Examination score higher than 24 at screening.

Exclusion criteria

* Diagnosis of Alzheimer's disease. * Any medical condition that could explain the subject's cognitive deficits. * MRI scans having evidence of pre-specified brain abnormalities. * History of stroke. * Vitamin B12 or folate deficiency. * Skin cancers and any cancer that is being actively treated. * Diagnosis of schizophrenia or recurrent mood disorder. * Abnormal kidney function. * Concomitant use of any study prohibitive medication.

Design outcomes

Primary

Measure	Time frame
To determine the effects on change from baseline on brain atrophy	pre-dose, Months 6, 12, 18, 24 and Washout

Secondary

Measure	Time frame
To determine the presence of other biomarkers of neuronal degeneration	Day 1

Other

Measure	Time frame	Description
Change from baseline in cognitive performance	pre-dose, Month 6, Month 12, Month18, Month 24	rate of cognitive decline
Change from baseline in global clinical status	pre-dose, Month 6, Month 12, Month 18, Month 24	—

Outcome results

None listed

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