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Cognitive Dysfunction in Chronic and Persistent Immune Thrombocytopenia
Prevalence, Reproducibility, and Feasibility of Longitudinal Assessment of Neurocognitive Dysfunction in Adults with Chronic and Persistent Immune Thrombocytopenia (COGFIT)
Who can join
Ages 18 and older · All sexes
Full 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 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.
About the study
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.
Sponsor: Massachusetts General Hospital · Participants: 100 · Started: Sep 15, 2024
Contact the study team
- Debbie Jiang, MD · Phone: 617-724-4000
Official record on ClinicalTrials.gov — NCT06817395
Locations in the U.S.
| Massachusetts | Massachusetts General Hospital, Boston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.