Fatigue and Cognitive Dysfunction After Allogeneic Stemcell Transplantation, Prospective PET Study

NCT06363396 | Recruiting

• 1 other identifier: K 2023-7081
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is the academic study and continuation and further development of a prior project under the leadership of Professor LeBlanc. Patients undergoing allogenic stem cell transplantation are followed up in the outpatient clinic. Here, patients are offered participation the fatigue study measuring both fatigue and cognitive impairment systematically by international standard. Previous study by Boberg et al suggested distinct mRNA and proteomic profiles segregating fatigued from non-fatigued patients as well as patients with or without cognitive impairment. A larger well-defined patient cohort is necessary to confirm these results. Investigators aim to identify specific sets of proteins in the CSF that can serve as potential biomarkers of cognitive dysfunction and/or fatigue. This will be performed with two methods:

• by using mass spectrometry-based proteomics approaches
• Olink technology PET examinations will be performed on both fatigued and non-fatigued. We will utilize the second generation TSPO radioligand \[ 11C\]PBR28 as well as the SV2A radioligand \[ 11C\]UCB-J, both showing high signal-to-noise ratio and adequate test-retest properties.

Conditions

Fatigue; Cognitive Dysfunction

Outcome Measures

Primary Outcomes (3)

• Results of cognitive tests

  Measured by CANTAB and Geras panels

  2024-2027

• Potential biomarkers for fatigue and cognitive dysfunction

  Measured in blood and csf by using mass spectrometry-based proteomics approaches and Olink technology by selecting different panels of proteins based on data available in the literature.

  2024-2027

• PET results

  The primary analysis will focus on the frontal cortex.

  2024-2027

Secondary Outcomes (1)

• Global analyses of the neural connections

  2024-2027

Study Arms (2)

Patients with fatigue and cognitive dysfunction

Patients that are one to five years after allogeneic stem cell transplantation and have signs of fatigue and cognitive dysfunction measured by international standarts.

Patients without fatigue and cognitive dysfunction

Patients that are one to five years after allogeneic stem cell transplantation and have no detectable signs of fatigue and cognitive dysfunction measured by international standarts.

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 20-75, both male and female who are 1-5 years after allogeneic stem cell transplantation.

You may qualify if:

• status 1-5 years after HSCT
• no known CNS disorders or psychiatric disturbances

You may not qualify if:

• prior TBI or CNS irradiation / intrathecal therapy
• known neurological or psychiatric disorder
• time less then 1 year or over 5 years after transplantation

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska

Stockholm, 14186, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples for genotyping for radioligands prior to PET investigation

MeSH Terms

Conditions

Fatigue; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 12, 2024
• Study Start: February 22, 2024
• Primary Completion: February 22, 2026
• Study Completion (Estimated): February 22, 2027
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)