← Back to Search

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
Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can take pills by mouth.
Select...
I can attend all required study visits.
Select...
I have been on a stable dose of medication for memory problems for at least 90 days.
Select...
My brain scan shows no significant issues contributing to dementia.
Select...
I have been diagnosed with mild memory loss and my mental state exam score is between 22-28.
Select...
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.
Select...
I have not had a heart attack or unstable heart disease in the past year.
Select...
I currently have active cancer.
Select...
I haven't had a brain or mental health issue in the last 3 years that could lead to memory loss.
Select...
I cannot or do not want to have MRI and PET scans.
Select...
I have had or currently have blood clots.
Select...
I have a serious blood or clotting disorder.
Select...
I have a low neutrophil count or a history of it.
Select...
I have been hospitalized more than twice in the past year for severe lung problems.
Select...
My high blood pressure is not well-managed.
Select...
I have sleep apnea that has not been treated.
Select...
I do not have serious liver or kidney disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

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 more
Secondary 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 • NCT00179621
80%
Neutropenia
55%
Thrombocytopenia
46%
Diarrhoea
26%
Rash
26%
Constipation
25%
Fatigue
23%
Nausea
23%
Pruritus
22%
Oedema Peripheral
22%
Nasopharyngitis
17%
Dyspnoea
17%
Cough
17%
Leukopenia
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%
Weight Decreased
9%
Haematoma
9%
Oral Herpes
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%
Dyspepsia
6%
Gastroenteritis Viral
6%
Dry Mouth
6%
Rhinitis
6%
Myalgia
6%
Hypoalbuminaemia
6%
Dyspnoea Exertional
6%
Depression
6%
Peripheral Sensory Neuropathy
6%
Iron Overload
4%
Anxiety
4%
Contusion
4%
Pharyngitis
4%
Epistaxis
4%
Pulmonary Embolism
4%
Oedema
4%
Neck Pain
4%
Petechiae
4%
Hypomagnesaemia
3%
Lower Respiratory Tract Infection
3%
Fall
3%
Wound
3%
Atrial Fibrillation
3%
Cardiac Failure
3%
Sciatica
3%
Hyperhidrosis
3%
Febrile Neutropenia
3%
Flatulence
3%
Cystitis
1%
Refractory Anaemia with an excess of blasts
1%
Injury
1%
Transfusion Reaction
1%
Phlebitis
1%
Pain
1%
Non-cardiac Chest Pain
1%
Pancytopenia
1%
Hypoxia
1%
Sinusitis
1%
Staphylococcal Sepsis
1%
Dysuria
1%
Cataract
1%
Intussusception
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

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
64 Previous Clinical Trials
14,617 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,704 Previous Clinical Trials
28,033,227 Total Patients Enrolled
The Cleveland ClinicOTHER
1,037 Previous Clinical Trials
1,366,981 Total Patients Enrolled

Media Library

Lenalidomide (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT04032626 — Phase 2
Amyloid Plaque Research Study Groups: Lenalidomide, Placebo
Amyloid Plaque Clinical Trial 2023: Lenalidomide Highlights & Side Effects. Trial Name: NCT04032626 — Phase 2
Lenalidomide (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04032626 — Phase 2
~1 spots leftby Sep 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top