Phase II Clinical Trial of Interleukin-2 in AD
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ClinicalTrials.gov Identifier: NCT06096090 |
Recruitment Status :
Recruiting
First Posted : October 23, 2023
Last Update Posted : December 7, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer Disease | Drug: Interleukin-2 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Clinical Trial of Interleukin-2 (IL-2) in Patients With Mild to Moderate Alzheimer's Disease |
Actual Study Start Date : | March 17, 2023 |
Estimated Primary Completion Date : | December 30, 2025 |
Estimated Study Completion Date : | December 30, 2025 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Aldesleukin every 4 weeks |
Drug: Interleukin-2
Low dose Interleukin-2 (Aldesleukin) administration to expand Regulatory T cells |
Active Comparator: Aldesleukin every 2 weeks |
Drug: Interleukin-2
Low dose Interleukin-2 (Aldesleukin) administration to expand Regulatory T cells |
Placebo Comparator: Placebo |
Drug: Placebo
Placebo administration |
- To assess the safety and the tolerability of IL-2 in AD patients [ Time Frame: 6 months treatment phase ]
Primary endpoint:
- Number of participants with adverse events and with abnormal laboratory findings (serum chemistry, hematology)
- To investigate the impact of IL-2 administration on the blood Treg population in AD patients [ Time Frame: 6 months treatment phase ]
Secondary Endpoint:
- Change in Treg percentage out of total CD4 cells
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years to 86 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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.
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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.
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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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06096090
Contact: Alireza Faridar, MD | 7134411150 | afaridar@houstonmethodist.org |
United States, Texas | |
Houston Methodist Research Institute | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Alireza Faridar 713-441-1150 afaridar@houstonmethodist.org |
Responsible Party: | Alireza Faridar, Assistant Professor, The Methodist Hospital Research Institute |
ClinicalTrials.gov Identifier: | NCT06096090 |
Other Study ID Numbers: |
PRO00030798 |
First Posted: | October 23, 2023 Key Record Dates |
Last Update Posted: | December 7, 2023 |
Last Verified: | December 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders |
Mental Disorders Interleukin-2 Antineoplastic Agents Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |