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Immunomodulator
Lenalidomide for Mild Cognitive Impairment (MCLENA-1 Trial)
Phase 2
Recruiting
Led By Marwan N Sabbagh, M.D.
Research Sponsored by St. Joseph's Hospital and Medical Center, Phoenix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ability to take oral medications
Ability to attend all study visits
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
MCLENA-1 Trial Summary
This trial will investigate whether the immunomodulator lenalidomide can help treat Alzheimer's by reducing inflammation.
Who is the study for?
This trial is for men and women aged 50-89 with amnestic MCI, a type of memory loss. Participants need an MMSE score of 22-28, stable health conditions, and must not be at risk of pregnancy. They should have no severe diseases or recent psychiatric disorders that could affect dementia.Check my eligibility
What is being tested?
The MCLENA-1 trial tests if Lenalidomide can help people with mild cognitive impairment by reducing inflammation in the brain. Patients will either receive Lenalidomide or a placebo to compare effects.See study design
What are the potential side effects?
Lenalidomide may cause side effects like blood disorders, increased risk of infections, fatigue, dizziness, rash or itching. It's important to monitor these symptoms closely during the trial.
MCLENA-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take pills by mouth.
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I can attend all required study visits.
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I have been on a stable dose of medication for memory problems for at least 90 days.
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My brain scan shows no significant issues contributing to dementia.
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I have been diagnosed with mild memory loss and my mental state exam score is between 22-28.
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I am a woman who has been menopausal for at least 2 years or am surgically sterile.
MCLENA-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in cognition as assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) total score
Change in cognition as assessed by the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) total score
Change in cognition as assessed by the Clinical Dementia Rating - Sum of Boxes (CDR-SOB) total score
+1 moreSecondary outcome measures
Monitoring and recording of all adverse events (AEs) and serious adverse events (SAEs)
Other outcome measures
Change in blood inflammatory markers
Change in brain amyloid loads
Change in neurodegeneration
Side effects data
From 2010 Phase 3 trial • 205 Patients • NCT0017962180%
Neutropenia
55%
Thrombocytopenia
46%
Diarrhoea
26%
Rash
26%
Constipation
25%
Fatigue
23%
Nausea
23%
Pruritus
22%
Oedema Peripheral
22%
Nasopharyngitis
17%
Leukopenia
17%
Dyspnoea
17%
Cough
17%
Headache
17%
Muscle Spasms
17%
Back Pain
16%
Pyrexia
16%
Upper Respiratory Tract Infection
14%
Anaemia
14%
Dry Skin
14%
Asthenia
13%
Respiratory Tract Infection
12%
Vertigo
12%
Vomiting
12%
Abdominal Pain Upper
12%
Dizziness
12%
Paraesthesia
12%
Decreased Appetite
12%
Acute Myeloid Leukaemia
10%
Hypertension
10%
Gastroenteritis
10%
Abdominal Pain
10%
Hypokalaemia
10%
Oropharyngeal Pain
10%
Bronchitis
10%
Alanine Aminotransferase Increased
9%
Oral Herpes
9%
Weight Decreased
9%
Haematoma
9%
Arthralgia
9%
Insomnia
9%
Urinary Tract Infection
7%
Influenza
7%
Pneumonia
7%
Non-Cardiac Chest Pain
7%
Influenza Like Illness
7%
Pain in Extremity
7%
Musculoskeletal Pain
6%
Gastroenteritis Viral
6%
Dyspepsia
6%
Dry Mouth
6%
Rhinitis
6%
Myalgia
6%
Hypoalbuminaemia
6%
Dyspnoea Exertional
6%
Depression
6%
Peripheral Sensory Neuropathy
6%
Iron Overload
4%
Epistaxis
4%
Anxiety
4%
Contusion
4%
Pharyngitis
4%
Pulmonary Embolism
4%
Oedema
4%
Neck Pain
4%
Petechiae
4%
Hypomagnesaemia
3%
Fall
3%
Wound
3%
Lower Respiratory Tract Infection
3%
Atrial Fibrillation
3%
Cardiac Failure
3%
Sciatica
3%
Hyperhidrosis
3%
Febrile Neutropenia
3%
Flatulence
3%
Cystitis
1%
Transfusion Reaction
1%
Refractory Anaemia with an excess of blasts
1%
Phlebitis
1%
Pain
1%
Sinusitis
1%
Pancytopenia
1%
Non-cardiac Chest Pain
1%
Injury
1%
Cataract
1%
Dysuria
1%
Staphylococcal Sepsis
1%
Intussusception
1%
Hypoxia
1%
Deep Vein Thrombosis
1%
Lung Disorder
1%
Generalised Oedema
1%
Erysipelas
1%
Infection
1%
Urosepsis
1%
Chronic Obstructive Pulmonary Disease
1%
Pneumonia Aspiration
1%
Respiratory Failure
1%
Leukaemia
1%
Myelodysplastic syndrome
1%
Anxiety Disorder
1%
Diabetes Mellitus Inadequate Control
1%
Hyperglycaemia
1%
Hypoglycaemia
1%
Urinary Incontinence
1%
Urine Human Chorionic Gonadotropin Abnormal
1%
Pyoderma Gangrenosum
1%
Cytogenetic Abnormality
1%
Chest Pain
1%
Musculoskeletal Chest Pain
1%
Lung Cancer Metastatic
1%
Mood Altered
1%
Tooth Disorder
1%
Venous Thrombosis
1%
International normalised Ratio Increased
1%
Fibromyalgia
1%
Renal Failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Lenalidomide 5 mg
Lenalidomide 10 mg
Placebo Crossover to 5 mg Open-label Period
MCLENA-1 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: LenalidomideExperimental Treatment1 Intervention
Lenalidomide 10 mg/day taken daily orally for 12 months of treatment followed by 6 months washout. The trial will last 18 month in duration.
Group II: PlaceboPlacebo Group1 Intervention
Placebo taken daily orally for 12 months of treatment followed by 6 months washout. The trial will last 18 month in duration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide 10 mg
2005
Completed Phase 3
~210
Find a Location
Who is running the clinical trial?
The Cleveland ClinicOTHER
1,030 Previous Clinical Trials
1,365,528 Total Patients Enrolled
St. Joseph's Hospital and Medical Center, PhoenixLead Sponsor
63 Previous Clinical Trials
14,587 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,895 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with multiple myeloma before.I have not had a heart attack or unstable heart disease in the past year.I currently have active cancer.My thyroid condition is stable, treated for at least 6 months.I can take pills by mouth.I cannot or do not want to have MRI and PET scans.I can attend all required study visits.I haven't had a brain or mental health issue in the last 3 years that could lead to memory loss.I have had or currently have blood clots.I have a serious blood or clotting disorder.You have a Hachinski ischemic score of 4 or lower.I have been on a stable dose of medication for memory problems for at least 90 days.I have a low neutrophil count or a history of it.My brain scan shows no significant issues contributing to dementia.Your score on the geriatric depression scale is 10 or lower.You have been diagnosed with a major psychiatric disorder according to the DSM IV criteria.I have been hospitalized more than twice in the past year for severe lung problems.I haven't taken any experimental drugs recently.You have a history of drinking too much alcohol or using drugs.My high blood pressure is not well-managed.My prostate cancer is stable, as confirmed by my doctor.I am between 50 and 89 years old.I have sleep apnea that has not been treated.I have been diagnosed with mild memory loss and my mental state exam score is between 22-28.I do not have serious liver or kidney disease.I am a woman who could become pregnant.I am a woman who has been menopausal for at least 2 years or am surgically sterile.Your medical records show that you have amnestic mild cognitive impairment.
Research Study Groups:
This trial has the following groups:- Group 1: Lenalidomide
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment criteria for this trial restricted to individuals over 25 years of age?
"According to the requirements for enrollment, participants must be over 50 years old and no older than 89."
Answered by AI
What therapeutic applications is Lenalidomide 10 mg typically utilized for?
"Lenalidomide 10 mg is employed to manage multiple myeloma, relapsed/refractory lymphoma, chronic lymphocytic leukemia and some other diseases after two antecedent systemic chemotherapy regimens."
Answered by AI
Could you please detail the scope of previous research involving Lenalidomide 10 mg?
"Lenalidomide 10 mg was initially studied in 2004 by the Midwest Center for Hematology Oncology. To date, 18659 trials have been finalized, with 268 active and recruiting studies taking place across Las Vegas, Nevada."
Answered by AI
What is the highest amount of individuals partaking in this clinical research?
"That's correct. Based on the clinicaltrials.gov listing, this clinical trial is in need of additional participants and was first posted on July 22nd 2020. The most recent update came out April 14th 2022 with a target goal of 30 patients across 2 research centres."
Answered by AI
Has the Federal Drug Administration sanctioned Lenalidomide 10 mg for use?
"Our team has determined that lenalidomide 10 mg is relatively safe, as it received a score of 2. This assessment was based on the fact that this drug is in Phase 2 trials where there are some supporting safety studies but no evidence for efficacy yet."
Answered by AI
Who is the ideal cohort for participating in this research?
"This investigation is open to 30 adults with senile plaques aged between 50 and 89. Eligibility necessitates that the participants are male or female outpatients, have a documented Mini Mental State Exam (MMSE) score of 22-28, be able to take oral medicines, have an Hachinski Ischemic Score ≤4 on their Geriatric Depression Scale test which must also rate below 10, possess functional vision & hearing aptitudes for study procedures; those taking cholinesterase inhibitors/memantine must remain on stable doses from at least 90 days before commencement (Week 00), and cannot exhibit intolerance or lack of"
Answered by AI
Is the patient enrollment for this trial still ongoing?
"As per clinicaltrials.gov, this trial is actively enrolling potential participants. This project was initially created on July 22nd 2020 and most recently updated on April 14th 2022."
Answered by AI
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