What this study is
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.
Study details
- Official title
- Prevalence, Reproducibility, and Feasibility of Longitudinal Assessment of Neurocognitive Dysfunction in Adults With Chronic and Persistent Immune Thrombocytopenia (COGFIT)
- Sponsor
- Massachusetts General Hospital
- Conditions
- Immune Thrombocytopenia
- Enrolling
- 100 people
- Starts
- 2024-09-15
- Est. completion
- 2028-09-15
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMassachusetts General Hospital
Boston, Massachusetts, United States
- Debbie C Jiang, MD · Contact617-724-4000dcjiang@mgh.harvard.edu
Recruiting
Study team
Sponsor
Massachusetts General Hospital
Study ID 2024P000181
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.