Lenalidomide 10 mg for Senile Plaques

Phase-Based Progress Estimates

Effectiveness

Safety

Senile Plaques+7 More

Lenalidomide 10 mg - Drug

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Eligibility

18+

All Sexes

What conditions do you have?

Select

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

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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

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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 - 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.

References