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

Alzheimer's Disease Clinical Trial

— CT05  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01723670
• Other study ID #: CCD-1109-PR-0072
• Status: Withdrawn
• Phase: Phase 2
• First received: October 31, 2012
• Last updated: February 9, 2015
• Start date: December 2012
• Est. completion date: March 2016

Study information

• Verified date: February 2015
• Source: CERESPIR
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 64 Years

Eligibility

Inclusion Criteria:

• One or two ?4 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cognition Disorders
• Mild Cognitive Impairment
• Nerve Degeneration

Intervention

Drug:
• CHF 5074 1x
oral tablet, 1x, once a day for 24 months
• CHF 5074 2x
oral tablet, 2x, once a day for 24 months
• Placebo
oral tablet,once a day for 24 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CERESPIR

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in cognitive performance	rate of cognitive decline	pre-dose, Month 6, Month 12, Month18, Month 24	No
Other	Change from baseline in global clinical status		pre-dose, Month 6, Month 12, Month 18, Month 24	No
Primary	To determine the effects on change from baseline on brain atrophy		pre-dose, Months 6, 12, 18, 24 and Washout	No
Secondary	To determine the presence of other biomarkers of neuronal degeneration		Day 1	No
Secondary	To determine the presence of other biomarkers of neuronal degeneration		Month 24	No