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Recruiting NCT06817395

Cognitive Dysfunction in Chronic and Persistent Immune Thrombocytopenia

Trial Parameters

Condition Immune Thrombocytopenia
Sponsor Massachusetts General Hospital
Study Type OBSERVATIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-09-15
Completion 2026-09-15

Brief 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 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 s

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