Evaluating cognitive dysfunction in patients with immune thrombocytopenia
Prevalence, Reproducibility, and Feasibility of Longitudinal Assessment of Neurocognitive Dysfunction in Adults with Chronic and Persistent Immune Thrombocytopenia (COGFIT)
This study is trying to see how common and serious thinking problems are in adults with immune thrombocytopenia and if these issues are linked to factors like fatigue and depression.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | fostamatinib |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06817395 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess cognitive impairment in adults with chronic and persistent immune thrombocytopenia (ITP) using a cognitive function test battery. Participants will undergo neurocognitive testing and complete surveys regarding their quality of life, fatigue, depression, and cognitive symptoms. The study seeks to determine the prevalence and extent of cognitive dysfunction in ITP patients and explore associated risk factors, as well as the feasibility of longitudinal cognitive testing over time.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of persistent or chronic ITP.
Not a fit: Patients with pre-existing cognitive impairment due to dementia, stroke, or other neurological diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of cognitive issues in ITP patients, potentially leading to improved management strategies.
How similar studies have performed: While cognitive impairment in ITP is a relatively novel area of investigation, similar studies in other chronic conditions have shown cognitive dysfunction, suggesting potential relevance.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Pre-existing diagnosis of cognitive impairment from dementia, stroke, or other neurologic disease. * Active psychiatric disorder, defined as uncontrolled major depression, schizophrenia, severe anxiety, or active alcohol or drug abuse. * Active malignancy, requiring or likely to require chemotherapeutic or surgical treatment, except for non-melanoma skin cancer. * Brain tumor or cranial surgery within the past year. * Significant hearing or vision impairment that would preclude the ability to complete neurocognitive testing via a virtual platform.
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Debbie Jiang, MD
- Email: dcjiang@mgh.harvard.edu
- Phone: 617-724-4000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.