Evaluation of Effects of Multiple Dose Regimens of CHF 50... | NCT01723670

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

NCT01723670

Sponsor

CERESPIR

Status

Withdrawn

Last Update Posted

Feb 10, 2015Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Alzheimer's Disease

Interventions

CHF 5074 1x
CHF 5074 2x
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Mar 2016Estimated

Completion Date

Mar 2016Estimated

First Submitted Date

Oct 31, 2012

First Submission Date that Met QC Criteria

Nov 6, 2012

First Posted Date

Nov 8, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2015

Last Update Posted Date

Feb 10, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CHF 5074 1x	Experimental	oral tablet, multidose	Drug: CHF 5074 1x
CHF 5074 2x	Experimental	oral tablet, multidose	Drug: CHF 5074 2x
Placebo	Placebo Comparator	placebo, oral tablet, multidose	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CHF 5074 1x	Drug	oral tablet, 1x, once a day for 24 months	CHF 5074 1x

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
To determine the presence of other biomarkers of neuronal degeneration		Day 1
To determine the presence of other biomarkers of neuronal degeneration		Month 24

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joel S Ross, MD	Memory Enhancement Center of America	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided