NCT04451213

Brief Summary

CF is a complex, inherited illness that can affect many organs of the body. The investigators have found that some patients with CF have reported more problems with memory than would be expected at their age and that patients appear to be using memory strategies to overcome memory loss. The investigators intend to objectively test memory and examine MRI images of the brain of patients with CF.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 23, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2022

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

1.3 years

First QC Date

January 21, 2020

Last Update Submit

August 30, 2023

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • Objective memory scores

    up to one year

Secondary Outcomes (1)

  • MRI head

    up to one year

Study Arms (1)

experimental

EXPERIMENTAL
Diagnostic Test: MRI head

Interventions

MRI headDIAGNOSTIC_TEST

MRI head

experimental

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female, aged greater or equal to 30 years
  • A diagnosis of CF
  • Primary school education or above
  • Able to provide informed consent

You may not qualify if:

  • Contraindications to MRI as found on the CUBRIC screening form (including presence of indwelling metal devices/clips)
  • Existing neurological disease affecting cognition (including stroke and traumatic brain injury)
  • Existing diagnosis of dementia documented in medical notes
  • Vascular complications of diabetes
  • Requiring supplemental oxygen -long term or overnight
  • Hepatic failure
  • Overt psychiatric disorders
  • Past or present alcohol or recreational drug misuse
  • Pregnancy
  • Current infection Smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiff and VAle University Health Board

Cardiff, United Kingdom

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2020

First Posted

June 30, 2020

Study Start

August 23, 2021

Primary Completion

December 23, 2022

Study Completion

December 23, 2022

Last Updated

August 31, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)