Evaluation of Effects of Multiple Dose Regimens of CHF 5074 on Potential Biomarkers of Neurodegeneration in Subjects With Mild Cognitive Impairment (CT05)

CereSpir

Status and phase: Withdrawn; Phase 2

Conditions: Alzheimer's Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01723670

CCD-1109-PR-0072

Details and patient eligibility

About

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.

Sex: All

Ages: 45 to 64 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups, including a placebo group

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

Placebo

Placebo Comparator group

Description:

placebo, oral tablet, multidose

Treatment:

Drug: Placebo