Status:
RECRUITING
Phase II Clinical Trial of Interleukin-2 in AD
Lead Sponsor:
The Methodist Hospital Research Institute
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50-86 years
Phase:
PHASE2
Brief Summary
Neuroinflammation is a significant component of Alzheimer disease (AD). Our group recently demonstrated that regulatory T cells (Tregs) have a compromised phenotype and reduced suppressive function in...
Eligibility Criteria
Inclusion
- Diagnosis of probable Alzheimer disease according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria
- Male or female age 50 to 86 years
- MMSE between 12-26
- Total bilirubin less than or equal to 1.5mg/dL
- Alanine aminotransferase level (ALT) and aspartate aminotransferase (AST) less than or equal to two times normal,
- Albumin greater than or equal to 3.0mg/dL
- Serum creatinine less than or equal to 1.5 mg/dL
- White Blood Count (WBC) \>3,500/mm3; platelets \>100,000/mm3; hematocrit (HCT) \>32%.
- INR\<1.4 If on medications affecting cognition (rivastigmine, galantamine, donepezil, memantine), participants must be on stable dosage for at least 4 weeks prior to screening and should remain at a stable dosage during the course of the study.
- English language speaking
- Formal education of eight or more years
- Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening
Exclusion
- Serious, active bacterial, fungal or viral infection, active or latent tuberculosis
- History of severe pulmonary dysfunction
- Severe cardiac dysfunction defined as left ventricular ejection fraction \<40% if an echocardiogram is medically indicated to clarify ongoing symptoms or EKG findings.; a history of non-controlled cardiac arrhythmias; history of cardiac tamponade; Unstable angina or MI in the last 3 months
- Hypersensitivity or allergy to IL-2
- History of bowel ischemia/perforation, or GI bleeding requiring surgery
- Hospitalization or change of chronic concomitant medication within one month prior to screening.
- History of hemorrhage or infarct or \> 3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g. abscess or brain tumor with the exception of small incidental meningiomas) in prior CT or MRI.
- Clinical or laboratory findings consistent with:
- Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Jacob-Creutzfeld Disease, Down's syndrome, etc.)
- Other neurodegenerative condition (Parkinson's disease, amyotrophic lateral sclerosis, etc.)
- Seizure disorder
- History of infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, vitamin B12 or folate deficiency, other laboratory values, etc.)
- Clinically significant abnormal T4 or TSH
- A current DSM-V diagnosis of active major depression, schizophrenia or bipolar disorder. Patients with depressive symptoms successfully managed by a stable dose of an antidepressant are allowed entry.
- Clinically significant, advanced or unstable disease that may interfere with outcome evaluations, such as:
- Respiratory insufficiency
- Bradycardia (\<45/min.) or tachycardia (\>100/min.)
- Poorly managed hypertension (systolic \>160 mm Hg and/or diastolic \>95 mm Hg) or hypotension (systolic \<90 mm Hg and/or diastolic \<60 mm Hg)
- Uncontrolled diabetes defined by HbA1c \>8%
- History of cancer within 3 years of screening with the exception of fully excised non-melanoma skin cancers or non-metastatic prostate cancer that has been stable for at least 6 months.
- History of acute/chronic hepatitis B or C and/or carriers of hepatitis B
- Disability that may prevent the patient from completing all study requirements (e.g. blindness, deafness, severe language difficulty, etc.).
- Within 4 weeks of screening visit or during the course of the study, concurrent treatment with antipsychotic agents (except risperidone ≤1.5 mg/day, quetiapine ≤100 mg/day, olanzapine ≤5 mg/day, and aripiprazole ≤10 mg/day), antiepileptics (except lamotrigine, gabapentin and pregabalin for nonseizure indications), centrally active anti-hypertensive drugs (e.g., clonidine, l-methyl dopa, guanidine, guanfacine, etc.), opiate analgesics, systemic corticosteroids, psychostimulants, antiparkinsonian medications (except for non-parkinsonian indications) and mood stabilizers (e.g., valproate, lithium), sedatives, and anxiolytics with the exception that use of short- to medium-acting benzodiazepines for treatment of insomnia is permitted, however, use of sedatives or hypnotics should be avoided for 8 hours before administration of cognitive tests.
- Nootropic drugs except stable AD meds (acetylcholinesterase inhibitors and memantine.
- Suspected or known drug or alcohol abuse, i.e. more than approximately 60 g alcohol (approximately 1 liter of beer or 0.5 liter of wine) indicated by elevated MCV significantly above normal value at screening
- Suspected or known allergy to any components of the study treatments.
- Intake of investigational drug within the previous 30 days or five half-lives of the investigational drug, whichever is longer.
- Exposure to passive immunotherapies for AD (e.g. monoclonal antibodies) within the previous 180 days to dosing, and BACE inhibitors within the previous 30 days to dosing.
- Chronic steroid or interferon therapy
- Contraindication to undergoing an LP including, but not limited to: inability to tolerate an appropriately flexed position for the time necessary to perform an LP; INR \>1.4 or other coagulopathy; platelet count of \<100,000/μL; infection at the desired lumbar puncture site; taking anti-coagulant medication within 90 days of screening (Note: low dose aspirin is permitted); suspected non-communicating hydrocephalus or intracranial mass; prior history of spinal mass or trauma.
- Any condition, which in the opinion of the investigator makes the patient unsuitable for inclusion.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06096090
Start Date
January 1 2022
End Date
December 30 2025
Last Update
May 23 2024
Active Locations (1)
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1
Houston Methodist Research Institute
Houston, Texas, United States, 77030