N/A
N=212
Examining Cognitive Function and Brain Abnormalities in Adults With Sickle Cell Disease
Anemia, Sickle Cell
Bottom Line
View on ClinicalTrials.gov: NCT00528801 ↗Enrolled (actual)
212
Serious AEs
—
Results posted
Nov 2009
Primary outcome: Primary: Wechsler Adult Intelligence Scale (WAIS)-III Performance IQ — 90.6; 95.9 Points on a scale — p=0.008
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- NP Battery (Behavioral); MRI (Procedure)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- UCSF Benioff Children's Hospital Oakland
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wechsler Adult Intelligence Scale (WAIS)-III Performance IQ |
90.6; 95.9 | 0.008 sig |
| SECONDARY Participants With Brain Lacunae as Measured by Clinical MRI |
19; 1 | 0.048 sig |
| SECONDARY Volume of Total Cortical Gray Matter as Measured by Volumetric MRI. |
543.5; 569.7 | — |
Summary
Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease that can cause intense pain episodes and may lead to organ failure. Preliminary studies have shown that adults with SCD may have brain abnormalities that contribute to problems with cognitive functioning, including attention and memory difficulties. This study will use brain magnetic resonance imaging (MRI) and neuropsychological testing to examine the differences in cognitive functioning in adults with SCD and adults without SCD.
212 subjects participated in this cross-sectional study consisting of screening questionnaires, a neuropsychological testing battery, and MRI testing. Enrollment into this study ended in May 2008.
Eligibility Criteria
Inclusion Criteria
Individuals who meet all of the following criteria are eligible for enrollment as cases into the study:
- Adult between the ages of 21 and 55
- African descent
- Proficient/fluent in English
- Hemoglobin electrophoresis confirming hemoglobin SS or SB0 (%A 40)
- Alcohol consumption exceeding 14 drinks/week if female, 21 drinks/week if male
- Drug abuse, defined as using non-prescribed medication
- History of claustrophobia and/or presence of metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body
- Pregnancy
- Baseline blood pressure > 140/90 on two repeated measurements. A second measurement is needed only if the first is > 140/90
- History of uncontrolled hypertension
- Any chronic disorder that may result in neurocognitive or brain dysfunction that is not secondary to SCD including:
- Inflammatory arterial disorders (lupus, polyarteritis)
- History of cancer requiring chemotherapy and/or radiation
- Untreated hyperlipidemia
- Diabetes
- Ongoing active infection such as HIV, tuberculosis, sarcoidosis
- History of chronic transfusion
- Chronic renal failure/Dialysis
- Chronic lung disease characterized by need for oxygen
- Morbid obesity (weight >115 kg)
- Heart disease: history of congestive heart failure, history of severe coronary artery disease characterized by angioplasty or surgery, or history of angina
- Active hepatitis or liver failure
- Acquired or congenital immune deficiency
- History of psychoses (delusions, hallucinations) and/or schizophrenia
- Neurodegenerative disorders
- Genetic disorder associated with neurocognitive dysfunction such as Down Syndrome
- Other chronic illness or disorder other than SCD that will adversely affect the subject's performance in the study
- Currently on Procrit or related drug that stimulates red blood cell production
Individuals who meet any of the following criteria are disqualified from enrollment as community controls in to the study:
- Hb electrophoresis other than AA
- Abnormal Hb (females: 40)
- Alcohol consumption exceeding 14 drinks/week if female, 21 drinks/week if male
- Drug abuse, defined as using non-prescribed medication
- History of claustrophobia and/or presence of metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body
- Pregnancy
- Baseline blood pressure > 140/90 on two repeated measurements. A second measurement is needed only if the first is > 140/90
- History of uncontrolled hypertension
- Any chronic disorder that may result in neurocognitive or brain dysfunction including:
- Inflammatory arterial disorders (lupus, polyarteritis)
- History of cancer requiring chemotherapy and/or radiation
- Untreated hyperlipidemia
- Diabetes
- Ongoing active infection such as HIV, tuberculosis, sarcoidosis
- History of chronic transfusion
- Chronic renal failure/Dialysis
- Chronic lung disease characterized by need for oxygen
- Morbid obesity (weight > 115 kg)
- Heart disease: history of congestive heart failure, history of severe coronary artery disease characterized by angioplasty or surgery, or history of angina
- Active hepatitis or liver failure
- Acquired or congenital immune deficiency
- History of psychoses (delusions, hallucinations) and/or schizophrenia
- Neurodegenerative disorders
- Genetic disorder associated with neurocognitive dysfunction such as Down Syndrome
- Other chronic illness or disorder that will adversely affect the subject's performance in the study
- Currently on Procrit or related drug that stimulates red blood cell production
Data sourced from ClinicalTrials.gov (NCT00528801). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.