Prevalence, Reproducibility, and Feasibility of Longitudinal Assessment of Neurocognitive Dysfunction in Adults with Chronic and Persistent Immune Thrombocytopenia (COGFIT)

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Individuals with immune thrombocytopenia (ITP) frequently report difficulties with attention and memory. The main question this study seeks to answer is: Do patients with ITP have evidence of cognitive impairment as detected by a cognitive function test battery? To address this issue, participants will take a cognitive function test and complete surveys on quality of life, fatigue, depression, and cognitive symptoms. The primary aim of the study is to evaluate for the presence and extent of cognitive impairment in patients with ITP. The study will also assess whether cognitive impairment in ITP is associated with patient-reported impacts on quality of life, fatigue, mood, and cognitive symptoms as well as clinical characteristics such as ITP disease and treatment history.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults aged ≥ 18 years

• A clinical diagnosis of persistent or chronic ITP, as defined by a history of platelet counts \<50 x 109/L on two occasions in the preceding 3 to 12 months or \>12 months, respectively, and documented response to at least 1 prior ITP-directed therapy. ITP-directed therapies include corticosteroids, intravenous immune globulin, Rho(D) immune globulin, splenectomy, thrombopoietin receptor agonists, and fostamatinib. Other qualifying agents used for the treatment of ITP are permissible with approval of the principal investigator.

• Ability to follow instructions in English.

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Debbie Jiang, MD
dcjiang@mgh.harvard.edu
617-724-4000
Time Frame
Start Date: 2024-09-15
Estimated Completion Date: 2028-09-15
Participants
Target number of participants: 100
Treatments
Adults with chronic or persistent ITP
Sponsors
Leads: Massachusetts General Hospital
Collaborators: Platelet Disorder Support Association (PDSA)

This content was sourced from clinicaltrials.gov