Cognitive Dysfunction in Chronic and Persistent Immune Thrombocytopenia

NCT06817395 | Recruiting

• 1 other identifier: 2024P000181
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Thrombocytopenia

Keywords

Cognitive impairment; Immune thrombocytopenia; ITP; Quality of life; Cognitive dysfunction; Cognition

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Secondary Outcomes (1)

• Feasibility of longitudinal assessments

  2 years

Study Arms (1)

Adults with chronic or persistent ITP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Platelet Disorder Support Association (PDSA): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (3)

• Frith J, Watson S, Bolton Maggs PH, Newton JL. Cognitive symptoms are common in immune thrombocytopenia and associate with autonomic symptom burden. Eur J Haematol. 2012 Mar;88(3):224-8. doi: 10.1111/j.1600-0609.2011.01730.x. Epub 2011 Dec 12.

  PMID: 22044734 BACKGROUND

• Mitchell E, Frith J, Newton J. Fatigue and cognitive impairment in immune thrombocytopenic purpura remain stable over time: short report from a longitudinal study. Br J Haematol. 2019 Sep;186(5):777-781. doi: 10.1111/bjh.15993. Epub 2019 May 23.

  PMID: 31119732 BACKGROUND

• Kuter DJ, Khan U, Maruff P, Daak A. Cognitive impairment among patients with chronic immune thrombocytopenia. Br J Haematol. 2024 Jul;205(1):291-299. doi: 10.1111/bjh.19495. Epub 2024 May 9.

  PMID: 38724473 BACKGROUND

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Debbie Jiang, MD

CONTACT

617-724-4000; dcjiang@mgh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 10, 2025
• Study Start: September 15, 2024
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2028
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)