COMPLETED

MCLENA-1: A Clinical Trial for the Assessment of Lenalidomide in Amnestic MCI Patients

Conditions

Cognitive Impairment, Mild Cognitive Dysfunction Amyloid Plaque Neurodegeneration Inflammation, Brain Alzheimer's disease Biomarkers Brain Amyloid Brain Imaging Cognition Immunomodulation

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Accumulating evidence indicates that inflammation is prominent both in the blood and central nervous system (CNS) of Alzheimer's disease (AD) patients. These data suggest that systemic inflammation plays a crucial role in the cause and effects of AD neuropathology. Capitalizing on the experience from a previous clinical trial with thalidomide, here, the investigators hypothesize that modulating both systemic and CNS inflammation via the pleiotropic immunomodulator lenalidomide is a putative therapeutic intervention for AD if administered at a proper time window during the course of the disease.

Official Title

MCLENA-1: A Phase II Clinical Trial for the Assessment of Safety, Tolerability, and Efficacy of Lenalidomide in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease

Quick Facts

Study Start:2020-07-22

Study Completion:2025-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04032626

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 89 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* In order to be eligible for this study, subjects must meet the following	* Subjects will be excluded if they have any of the condition listed below: 1. Current evidence or history within the last 3 years of a neurological or psychiatric illness that could contribute to dementia, including (but not limited to) epilepsy, focal brain lesion, Parkinson's disease, seizure disorder, head injury with loss of consciousness 2. DSM IV criteria for any major psychiatric disorder including psychosis, major depression and bipolar disorder. 3. Known history or self-reported alcohol or substance abuse. 4. Isolated living circumstances which would prohibit a study partner from providing sufficient and credible information about the participant. 5. Poorly controlled hypertension. 6. History of myocardial infarction or signs or symptoms of unstable coronary artery disease within the last year (including revascularization procedure/angioplasty). 7. Severe pulmonary disease (including chronic obstructive pulmonary disease) requiring more than 2 hospitalizations within the past year. 8. Untreated sleep apnea. 9. Any thyroid disease (unless euthyroid or on treatment for at least 6 months prior to screening). 10. Active neoplastic disease (except for skin tumors other than melanoma). Patients with a history of prior malignancy are eligible provided they were treated with curative intent and (i) do not require any longer any active therapy; (ii) being considered in complete remission; and (iii) after the Medical Monitor's assessment/approval of each case. 11. History of multiple myeloma. 12. Absolute neutropenia of \<750mm3, or history of neutropenia. 13. History of or current thromboembolism (including deep venous thrombosis). 14. Any clinically significant hepatic or renal disease (including presence of Hepatitis B or C antigen/antibody or an elevated transaminase levels of greater than two times the upper limit of normal (ULN) or creatinine greater than 1.5 x ULN). 15. Clinically significant hematologic or coagulation disorder including any unexplained anemia or a platelet count less than 100,000/μL at screening. 16. Use of any investigational drug within 30 days or within five half-lives of the investigational agent, whichever is longer. 17. Use any investigational medical device within two weeks before screening or after end of the present study. 18. Females who are at risk of pregnancy or are of child bearing age. 19. Any other disease or condition that, in the opinion of the investigator, makes the patient unsuitable to participate in this clinical trial. 20. Unwilling or unable to undergo MRI and PET imaging. 21. Cardiac pacemaker or defibrillator or other implanted device. 22. In the opinion of the Investigator, participation would not be in the best interest of the subject.

Inclusion Criteria

Exclusion Criteria

* In order to be eligible for this study, subjects must meet the following

* Subjects will be excluded if they have any of the condition listed below:
1. Current evidence or history within the last 3 years of a neurological or psychiatric illness that could contribute to dementia, including (but not limited to) epilepsy, focal brain lesion, Parkinson's disease, seizure disorder, head injury with loss of consciousness
2. DSM IV criteria for any major psychiatric disorder including psychosis, major depression and bipolar disorder.
3. Known history or self-reported alcohol or substance abuse.
4. Isolated living circumstances which would prohibit a study partner from providing sufficient and credible information about the participant.
5. Poorly controlled hypertension.
6. History of myocardial infarction or signs or symptoms of unstable coronary artery disease within the last year (including revascularization procedure/angioplasty).
7. Severe pulmonary disease (including chronic obstructive pulmonary disease) requiring more than 2 hospitalizations within the past year.
8. Untreated sleep apnea.
9. Any thyroid disease (unless euthyroid or on treatment for at least 6 months prior to screening).
10. Active neoplastic disease (except for skin tumors other than melanoma). Patients with a history of prior malignancy are eligible provided they were treated with curative intent and (i) do not require any longer any active therapy; (ii) being considered in complete remission; and (iii) after the Medical Monitor's assessment/approval of each case.
11. History of multiple myeloma.
12. Absolute neutropenia of \<750mm3, or history of neutropenia.
13. History of or current thromboembolism (including deep venous thrombosis).
14. Any clinically significant hepatic or renal disease (including presence of Hepatitis B or C antigen/antibody or an elevated transaminase levels of greater than two times the upper limit of normal (ULN) or creatinine greater than 1.5 x ULN).
15. Clinically significant hematologic or coagulation disorder including any unexplained anemia or a platelet count less than 100,000/μL at screening.
16. Use of any investigational drug within 30 days or within five half-lives of the investigational agent, whichever is longer.
17. Use any investigational medical device within two weeks before screening or after end of the present study.
18. Females who are at risk of pregnancy or are of child bearing age.
19. Any other disease or condition that, in the opinion of the investigator, makes the patient unsuitable to participate in this clinical trial.
20. Unwilling or unable to undergo MRI and PET imaging.
21. Cardiac pacemaker or defibrillator or other implanted device.
22. In the opinion of the Investigator, participation would not be in the best interest of the subject.

Contacts and Locations

Principal Investigator

Marwan N Sabbagh, M.D.

PRINCIPAL_INVESTIGATOR

St. Joseph's Hospital and Medical Center, Phoenix

Boris Decourt, PhD

STUDY_CHAIR

The Cleveland Clinic

Study Locations (Sites)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013

United States

Cleveland Clinic Lou Ruvo Center for Brain health

Las Vegas, Nevada, 89103

United States

Collaborators and Investigators

Sponsor: St. Joseph's Hospital and Medical Center, Phoenix

Marwan N Sabbagh, M.D., PRINCIPAL_INVESTIGATOR, St. Joseph's Hospital and Medical Center, Phoenix
Boris Decourt, PhD, STUDY_CHAIR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-22

Study Completion Date2025-05-31

Study Record Updates

Study Start Date2020-07-22

Study Completion Date2025-05-31

Terms related to this study

Keywords Provided by Researchers

Alzheimer's disease
Biomarkers
Brain Amyloid
Brain Imaging
Cognition
Immunomodulation

Additional Relevant MeSH Terms

Cognitive Impairment, Mild
Cognitive Dysfunction
Amyloid Plaque
Neurodegeneration
Inflammation, Brain