Cognitive Dysfunction in Chronic and Persistent Immune Thrombocytopenia

ConditionImmune Thrombocytopenia

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorMassachusetts General Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Participants with a history of chronic or persistent ITP without pre-existing diagnosis of cognitive impairment will be recruited from the outpatient non-malignant hematology clinic at Massachusetts General Hospital (MGH).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants

are grouped into 1 trial group

Group A: Adults with chronic or persistent ITP

Trial outcomes

Primary outcomes

Impairment of fluid cognition

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.

Time frame

Baseline

Secondary outcomes

Feasibility of longitudinal assessments

Completion of annual study visit by at least 50% of the enrolled study population over course of 2 years

Time frame

2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Platelet Disorder Support Association (PDSA)

Collaborator

Source ClinicalTrials.gov

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