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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2016-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CHF 5074 1x

oral tablet, multidose

Group Type EXPERIMENTAL

CHF 5074 1x

Intervention Type DRUG

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

CHF 5074 2x

oral tablet, multidose

Group Type EXPERIMENTAL

CHF 5074 2x

Intervention Type DRUG

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

Placebo

placebo, oral tablet, multidose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral tablet,once a day for 24 months

Interventions

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CHF 5074 1x

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

Intervention Type DRUG

CHF 5074 2x

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

Intervention Type DRUG

Placebo

oral tablet,once a day for 24 months

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No