Lenalidomide 10 mg for Senile Plaques

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Senile Plaques+7 More
Lenalidomide 10 mg - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will investigate whether the immunomodulator lenalidomide can help treat Alzheimer's by reducing inflammation.

Eligible Conditions
  • Senile Plaques
  • Cognitive Decline
  • Neurodegeneration
  • Mild Cognitive Impairment (MCI)
  • Inflammation, Brain

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 1 Secondary · Reporting Duration: 18 months

18 months
Change in blood inflammatory markers
Change in brain amyloid loads
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
Change in cognition as assessed by the Mini Mental State Examination (MMSE) total score
Change in neurodegeneration
Monitoring and recording of all adverse events (AEs) and serious adverse events (SAEs)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Lenalidomide 10 mg
83%Neutropenia
54%Diarrhoea
52%Thrombocytopenia
30%Nausea
29%Pruritus
28%Constipation
25%Fatigue
23%Nasopharyngitis
23%Pyrexia
22%Muscle Spasms
20%Abdominal Pain
20%Bronchitis
20%Headache
19%Oedema Peripheral
17%Rash
17%Upper Respiratory Tract Infection
17%Urinary Tract Infection
16%Musculoskeletal Pain
14%Pain in Extremity
14%Dry Skin
14%Cough
14%Asthenia
14%Dizziness
13%Hypertension
13%Vomiting
13%Dyspnoea
13%Insomnia
12%Acute Myeloid Leukaemia
12%Leukopenia
12%Abdominal Pain Upper
12%Back Pain
12%Decreased Appetite
9%Anaemia
9%Oropharyngeal Pain
9%Haematoma
9%Sinusitis
9%Gastroenteritis
9%Myalgia
7%Musculoskeletal Chest Pain
7%Conjunctivitis
7%Weight Decreased
7%Cataract
7%Dyspepsia
7%Dry Mouth
7%Influenza Like Illness
7%Lower Respiratory Tract Infection
7%Influenza
7%Arthralgia
7%Iron Overload
7%Anxiety
7%Alanine Aminotransferase Increased
6%Alopecia
6%Pain
6%Contusion
6%Fall
6%Phlebitis
6%Deep Vein Thrombosis
6%Oedema
6%Cystitis
6%Pharyngitis
6%Sciatica
6%Balance Disorder
6%Epistaxis
6%Hyperhidrosis
6%Petechiae
6%Wound
4%Rhinitis
4%Hypomagnesaemia
4%Dysuria
4%Pneumonia
4%Respiratory Tract Infection
4%Paraesthesia
4%Neck Pain
4%Hypokalaemia
4%Dyspnoea Exertional
4%Vertigo
3%Refractory Anaemia with an excess of blasts
3%Acute Myocardial Infarction
3%General Physical Health Deterioration
3%Septic Shock
3%Pulmonary Embolism
3%Febrile Neutropenia
3%Depression
1%Bone Marrow Failure
1%Cerebrovascular Accident
1%Erysipelas
1%Mucosal Inflammation
1%Renal Colic
1%Colon Cancer
1%Tachyarrhythmia
1%Hypotension
1%Skin Ulcer
1%Joint Sprain
1%Atrial Fibrillation
1%Pneumonia Legionella
1%Pyelonephritis
1%Bacteraemia
1%Anal Abscess
1%Bladder Cancer
1%Mood Altered
1%Bronchopneumonia
1%Cellulitis
1%Colorectal Cancer
1%Lung Disorder
1%Breast Cancer
1%Histiocytosis Haematophagic
1%Delirium
1%Confusional State
1%Cardiac Failure
1%Myocardial Infarction
1%Colitis
1%Intestinal Obstruction
1%Synovial Rupture
1%Humerus Fracture
1%Spinal Compression Fracture
1%Coma
1%Femoral Neck Fracture
1%Subdural Haematoma
1%Hyperglycaemia
1%Renal Failure
1%Cerebral Haemorrhage
1%Stress Urinary Incontinence
1%Orthostatic Hypotension
1%Arterial Occlusive Disease
1%Autoimmune Thrombocytopenia
1%Haemolysis
1%Splenomegaly
1%Pancytopenia
1%Arthritis
1%Joint Range of Motion Decreased
1%Flatulence
1%Urticaria
1%Non-Cardiac Chest Pain
1%Peripheral Sensory Neuropathy
1%Hypoalbuminaemia
This histogram enumerates side effects from a completed 2010 Phase 3 trial (NCT00179621) in the Lenalidomide 10 mg ARM group. Side effects include: Neutropenia with 83%, Diarrhoea with 54%, Thrombocytopenia with 52%, Nausea with 30%, Pruritus with 29%.

Trial Design

2 Treatment Groups

Lenalidomide
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

30 Total Participants · 2 Treatment Groups

Primary Treatment: Lenalidomide 10 mg · Has Placebo Group · Phase 2

Lenalidomide
Drug
Experimental Group · 1 Intervention: Lenalidomide 10 mg · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 18 months

Who is running the clinical trial?

The Cleveland ClinicOTHER
940 Previous Clinical Trials
1,407,312 Total Patients Enrolled
St. Joseph's Hospital and Medical Center, PhoenixLead Sponsor
58 Previous Clinical Trials
14,124 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,382 Previous Clinical Trials
3,447,306 Total Patients Enrolled
Marwan N Sabbagh, M.D.Principal InvestigatorSt. Joseph's Hospital and Medical Center, Phoenix
Boris Decourt, PhDStudy ChairThe Cleveland Clinic

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are female and surgically sterile (bilateral tubal ligation, oophorectomy, or hysterectomy) or postmenopausal for 2 years (no women at risk of pregnancy will be accepted in this study).
You have a documented diagnosis of amnestic MCI based on the most recent NIA-AA criteria (Albert et al., 2011), i.e.
You have a score of ≤ 10 on the Geriatric Depression Scale.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 30th, 2021

Last Reviewed: November 6th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.