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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
Must not have
History of multiple myeloma
History of myocardial infarction or signs/symptoms of unstable coronary artery disease within the last year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
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.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with multiple myeloma before.
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I have not had a heart attack or unstable heart disease in the past year.
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I currently have active cancer.
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I haven't had a brain or mental health issue in the last 3 years that could lead to memory loss.
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I cannot or do not want to have MRI and PET scans.
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I have had or currently have blood clots.
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I have a serious blood or clotting disorder.
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I have a low neutrophil count or a history of it.
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I have been hospitalized more than twice in the past year for severe lung problems.
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My high blood pressure is not well-managed.
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I have sleep apnea that has not been treated.
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I do not have serious liver or kidney disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
Monitoring and recording of all adverse events (AEs) and serious adverse events (SAEs)
Other study objectives
Change in blood inflammatory markers
Change in brain amyloid loads
Change in neurodegeneration
Side effects data
From 2010 Phase 3 trial • 205 Patients • NCT0017962183%
Neutropenia
54%
Diarrhoea
52%
Thrombocytopenia
30%
Nausea
29%
Pruritus
28%
Constipation
25%
Fatigue
23%
Pyrexia
23%
Nasopharyngitis
22%
Muscle Spasms
20%
Abdominal Pain
20%
Headache
20%
Bronchitis
19%
Oedema Peripheral
17%
Urinary Tract Infection
17%
Rash
17%
Upper Respiratory Tract Infection
16%
Musculoskeletal Pain
14%
Asthenia
14%
Dizziness
14%
Pain in Extremity
14%
Cough
14%
Dry Skin
13%
Vomiting
13%
Dyspnoea
13%
Insomnia
13%
Hypertension
12%
Acute Myeloid Leukaemia
12%
Abdominal Pain Upper
12%
Leukopenia
12%
Back Pain
12%
Decreased Appetite
9%
Haematoma
9%
Anaemia
9%
Sinusitis
9%
Gastroenteritis
9%
Myalgia
9%
Oropharyngeal Pain
7%
Dry Mouth
7%
Dyspepsia
7%
Influenza Like Illness
7%
Lower Respiratory Tract Infection
7%
Influenza
7%
Arthralgia
7%
Musculoskeletal Chest Pain
7%
Iron Overload
7%
Anxiety
7%
Alanine Aminotransferase Increased
7%
Weight Decreased
7%
Cataract
7%
Conjunctivitis
6%
Balance Disorder
6%
Phlebitis
6%
Deep Vein Thrombosis
6%
Oedema
6%
Pain
6%
Cystitis
6%
Pharyngitis
6%
Sciatica
6%
Epistaxis
6%
Alopecia
6%
Hyperhidrosis
6%
Petechiae
6%
Contusion
6%
Fall
6%
Wound
4%
Pneumonia
4%
Respiratory Tract Infection
4%
Rhinitis
4%
Paraesthesia
4%
Neck Pain
4%
Hypokalaemia
4%
Hypomagnesaemia
4%
Dyspnoea Exertional
4%
Dysuria
4%
Vertigo
3%
General Physical Health Deterioration
3%
Septic Shock
3%
Pulmonary Embolism
3%
Refractory Anaemia with an excess of blasts
3%
Acute Myocardial Infarction
3%
Febrile Neutropenia
3%
Depression
1%
Splenomegaly
1%
Anal Abscess
1%
Bronchopneumonia
1%
Mucosal Inflammation
1%
Cellulitis
1%
Bacteraemia
1%
Erysipelas
1%
Pneumonia Legionella
1%
Pyelonephritis
1%
Lung Disorder
1%
Breast Cancer
1%
Bladder Cancer
1%
Colon Cancer
1%
Colorectal Cancer
1%
Mood Altered
1%
Histiocytosis Haematophagic
1%
Confusional State
1%
Delirium
1%
Cardiac Failure
1%
Myocardial Infarction
1%
Tachyarrhythmia
1%
Intestinal Obstruction
1%
Femoral Neck Fracture
1%
Humerus Fracture
1%
Spinal Compression Fracture
1%
Subdural Haematoma
1%
Synovial Rupture
1%
Renal Colic
1%
Hyperglycaemia
1%
Cerebral Haemorrhage
1%
Cerebrovascular Accident
1%
Coma
1%
Stress Urinary Incontinence
1%
Orthostatic Hypotension
1%
Arterial Occlusive Disease
1%
Autoimmune Thrombocytopenia
1%
Pancytopenia
1%
Bone Marrow Failure
1%
Haemolysis
1%
Arthritis
1%
Joint Range of Motion Decreased
1%
Skin Ulcer
1%
Urticaria
1%
Non-Cardiac Chest Pain
1%
Peripheral Sensory Neuropathy
1%
Hypoalbuminaemia
1%
Joint Sprain
1%
Atrial Fibrillation
1%
Colitis
1%
Renal Failure
1%
Hypotension
1%
Flatulence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lenalidomide 10 mg
Placebo
Lenalidomide 5 mg
Placebo Crossover to 5 mg Open-label Period
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?
St. Joseph's Hospital and Medical Center, PhoenixLead Sponsor
67 Previous Clinical Trials
17,334 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,789 Previous Clinical Trials
28,188,302 Total Patients Enrolled
The Cleveland ClinicOTHER
1,053 Previous Clinical Trials
1,371,144 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.
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