Cognitive Dysfunction in Chronic and Persistent Immune Thrombocytopenia

Recruiting

• Conditions: Immune Thrombocytopenia

• Registration Number: NCT06817395
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

This is a longitudinal observational study that seeks to evaluate for the prevalence and extent of cognitive dysfunction in adults with persistent and chronic ITP. Following enrollment, subjects will complete neurocognitive testing using the NIH Toolbox Cognition Battery (NIHTB-CB). In addition, subjects will complete surveys for patient-reported outcomes of quality of life, fatigue, self-reported cognitive function, and depression. Background characteristics and relevant clinical history will be obtained through an enrollment survey and chart review. The primary aim of the study is to describe the prevalence and extent of cognitive impairment in ITP and explore associated risk factors. This study will also assess the feasibility of longitudinal cognitive testing in patients with ITP and describe any observed changes in cognition over time.

Study Timeline

• Study Start: 2024-09-15
• Study First Submitted: 2025-01-28
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-04
• Last Update Submitted: 2025-02-04
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10
• Primary Completion: 2026-09-15
• Study Completion: 2028-09-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impairment of fluid cognition	Baseline	Proportion of subjects with mild (T-score 1 to 2 standard deviations \[SDs\] below the normative mean) or major (\>2 SDs below the normative mean) impairment of the composite measure of fluid cognition, as detected on the NIH Toolbox cognition battery.

Secondary Outcome Measures

Name	Time	Method
Feasibility of longitudinal assessments	2 years	Completion of annual study visit by at least 50% of the enrolled study population over course of 2 years

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States