Donanemab for Alzheimer Disease

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Alzheimer Disease
Donanemab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying how safe and effective donanemab is in treating early Alzheimer's disease.

Video Summary

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Alzheimer Disease

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Baseline, Up to Week 76

Baseline through Week 76
Number or Participants with Anti-Donanemab Antibodies
Pharmacokinetics (PK): Average Serum Concentration at Steady State of Donanemab
Week 76
Brain
Change from Baseline in Brain Tau Deposition as Measured by Flortaucipir F18 PET Scan
Change from Baseline in Brain Volume as Measured by volumetric Magnetic Resonance Imaging (vMRI)
Change from Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)
Change from Baseline on the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living (ADCS-iADL) Score
Change from Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)
Change from Baseline on the Mini Mental State Examination (MMSE) Score
Change from Baseline on the integrated Alzheimer's Disease Rating Scale (iADRS)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Alzheimer Disease

Side Effects for

Donanemab Monotherapy (Donanemab-M)
25%Amyloid related imaging abnormality-oedema/effusion
15%Fall
14%Superficial siderosis of central nervous system
11%Nausea
10%Urinary tract infection
9%Arthralgia
8%Dizziness
8%Cerebral microhaemorrhage
8%Diarrhoea
8%Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits
8%Headache
7%Upper respiratory tract infection
6%Infusion related reaction
5%Vomiting
5%Anxiety
5%Depression
5%Nasopharyngitis
4%Pain in extremity
4%Pneumonia
4%Fatigue
3%Bronchitis
3%Cataract
3%Skin abrasion
3%Weight decreased
3%Asthenia
3%Back pain
3%Hypotension
2%Presyncope
2%Wrist fracture
2%Prostate cancer
2%Bursitis
2%Urinary incontinence
2%Conjunctival haemorrhage
2%Bradycardia
2%Sinus bradycardia
2%Hiatus hernia
2%Constipation
2%Abdominal pain
2%Dysphagia
2%Influenza
2%Arthropod sting
2%Skin laceration
2%Wound
2%Electrocardiogram qt prolonged
2%Prostatic specific antigen increased
2%Hypoglycaemia
2%Decreased appetite
2%Dehydration
2%Hyponatraemia
2%Arthritis
2%Osteoarthritis
2%Basal cell carcinoma
2%Benign lung neoplasm
2%Squamous cell carcinoma
2%Confusional state
2%Delusion
2%Acute kidney injury
2%Pollakiuria
2%Benign prostatic hyperplasia
2%Haemoptysis
2%Hot flush
2%Hypertension
2%Poor venous access
2%Palpitations
2%Pulmonary embolism
2%Syncope
2%Atrial fibrillation
2%Tinnitus
2%Anal incontinence
2%Gastrooesophageal reflux disease
2%Cellulitis
2%Covid-19
2%Skin infection
2%Bone contusion
2%Cerebellar microhaemorrhage
2%Essential tremor
2%Nightmare
2%Pulmonary mass
2%Rhinorrhoea
2%Sinus congestion
2%Upper-airway cough syndrome
2%Alopecia
2%Cataract operation
2%Orthostatic hypotension
1%Limb injury
1%Dyspnoea
1%Sciatica
1%Squamous cell carcinoma of skin
1%Heart rate irregular
1%Lymphocyte morphology abnormal
1%Seborrhoeic dermatitis
1%Vaccination complication
1%Foot fracture
1%Head injury
1%Urticaria
1%Optic disc haemorrhage
1%Facial bones fracture
1%Covid-19 pneumonia
1%Dysplastic naevus
1%Seborrhoeic keratosis
1%Neuroma
1%Cerebral infarction
1%Urinary retention
1%Bronchitis viral
1%Malnutrition
1%Vitamin b12 deficiency
1%Atypical fibroxanthoma
1%Dermatitis contact
1%Clostridium difficile colitis
1%Jaw fracture
1%Death
1%Cervical vertebral fracture
1%Glaucoma
1%Orthostatic hypertension
1%Hypoacusis
1%Bundle branch block right
1%Arteriovenous malformation
1%Ventricular extrasystoles
1%Eyelid ptosis
1%Dry mouth
1%Ocular hyperaemia
1%Faeces soft
1%Vitreous degeneration
1%Chapped lips
1%Cholelithiasis
1%Toothache
1%Soft tissue inflammation
1%Pruritus
1%Seasonal allergy
1%Fungal infection
1%Hordeolum
1%Oral herpes
1%Laryngitis
1%Lyme disease
1%Tooth abscess
1%Cataract operation complication
1%Clavicle fracture
1%Skin injury
1%Tooth fracture
1%Bacterial test positive
1%Blood pressure systolic increased
1%Weight increased
1%Glucose tolerance impaired
1%Biopsy skin
1%Cardiac murmur
1%Haemoglobin decreased
1%Hypercholesterolaemia
1%Hypomagnesaemia
1%Occult blood positive
1%Hyperglycaemia
1%Musculoskeletal chest pain
1%Rheumatoid arthritis
1%Synovial cyst
1%Osteochondritis
1%Mucoid degeneration of the anterior cruciate ligament
1%Neck pain
1%Spinal stenosis
1%Lung adenocarcinoma
1%Cognitive disorder
1%Gliosis
1%Lethargy
1%Neuropathy peripheral
1%Paraesthesia
1%Polyneuropathy
1%Sensory loss
1%Renal cyst
1%Uterine disorder
1%Atelectasis
1%Dyspnoea exertional
1%Hiccups
1%Blepharorrhaphy
1%Lens extraction
1%Peripheral venous disease
1%Adverse drug reaction
1%Chest pain
1%Gait disturbance
1%Small intestinal obstruction
1%Bacterial sepsis
1%Duodenal ulcer haemorrhage
1%Hip fracture
1%Sinus node dysfunction
1%Gastroenteritis
1%Anaemia
1%Extradural haematoma
1%Chest discomfort
1%Subdural haematoma
1%Non-small cell lung cancer stage ii
1%Chills
1%Breast cancer
1%Encephalopathy
1%Neuralgia
1%Migraine
1%Cerebrovascular accident
1%General physical health deterioration
1%Injection site pruritus
1%Anaemia of chronic disease
1%Bundle branch block left
1%Mitral valve incompetence
1%Drug eruption
1%Sinus arrest
1%Tachycardia
1%Occipital neuralgia
1%Patient elopement
1%Peripheral sensorimotor neuropathy
1%Visual impairment
1%Atrial flutter
1%Tremor
1%Lacrimation increased
1%Medical device site reaction
1%Sinus arrhythmia
1%Photopsia
1%Peripheral swelling
1%Pyrexia
1%Dry age-related macular degeneration
1%Dry eye
1%Photophobia
1%Colitis ischaemic
1%Lower respiratory tract infection
1%Viral upper respiratory tract infection
1%Sinusitis
1%Arthropod bite
1%Ligament sprain
1%Meniscus injury
1%Rib fracture
1%Synovial rupture
1%Tendon rupture
1%Traumatic haematoma
1%Blood pressure increased
1%C-reactive protein increased
1%Creatinine renal clearance decreased
1%Hyperkalaemia
1%Hypocalcaemia
1%Qrs axis abnormal
1%Lactic acidosis
1%Overweight
1%Facet joint syndrome
1%Jaw disorder
1%Joint effusion
1%Muscle spasms
1%Temporomandibular joint syndrome
1%Tendonitis
1%Hallucination
1%Initial insomnia
1%Insomnia
1%Irritability
1%Balance disorder
1%Dementia alzheimer's type
1%Drug withdrawal headache
1%Head discomfort
1%Glycosuria
1%Hydronephrosis
1%Nephrolithiasis
1%Hypoxia
1%Oropharyngeal pain
1%Sleep apnoea syndrome
1%Actinic keratosis
1%Dermatitis
1%Dermatitis allergic
1%Dermatitis bullous
1%Erythema
1%Ingrowing nail
1%Skin hyperpigmentation
1%Transient acantholytic dermatosis
1%Cardiac pacemaker insertion
1%Cardiac pacemaker replacement
1%Cryotherapy
1%Dental implantation
1%Intraocular lens implant
1%Skin cryotherapy
1%Tooth extraction
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT03367403) in the Donanemab Monotherapy (Donanemab-M) ARM group. Side effects include: Amyloid related imaging abnormality-oedema/effusion with 25%, Fall with 15%, Superficial siderosis of central nervous system with 14%, Nausea with 11%, Urinary tract infection with 10%.

Trial Design

2 Treatment Groups

Donanemab
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

1800 Total Participants · 2 Treatment Groups

Primary Treatment: Donanemab · Has Placebo Group · Phase 3

Donanemab
Drug
Experimental Group · 1 Intervention: Donanemab · 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
Donanemab
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, up to week 76

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,453 Previous Clinical Trials
3,118,925 Total Patients Enrolled
51 Trials studying Alzheimer Disease
24,895 Patients Enrolled for Alzheimer Disease
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)Study DirectorEli Lilly and Company
1,250 Previous Clinical Trials
365,753 Total Patients Enrolled
32 Trials studying Alzheimer Disease
15,984 Patients Enrolled for Alzheimer Disease

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
A person has an MMSE score of 20 to 28 if their score falls between 20 and 28 inclusive on the MMSE test.
for probable AD The text is saying that if a person meets certain criteria on a florbetapir PET scan, they are most likely to have Alzheimer's disease.
and who meets eligibility criteria Someone who will agree to help you participate in the study and meets the requirements listed is what is meant by a study partner.
prior to clinical evaluation People have been reporting gradual and progressive changes in their memory function for at least six months before they go to the doctor.
This text is about a certain medical test and states that the test does not apply to a certain group of people.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 16th, 2021

Last Reviewed: October 24th, 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.

Who else is applying?

What state do they live in?
North Carolina40.0%
Florida40.0%
Alabama20.0%
How old are they?
65+80.0%
18 - 6520.0%
What site did they apply to?
ARS- Neurology and Neurodiagnostics of Alabama25.0%
Ezy Medical Research25.0%
Suncoast Neuroscience Associates25.0%
Other25.0%
What portion of applicants met pre-screening criteria?
Met criteria80.0%
Did not meet criteria20.0%
Why did patients apply to this trial?
  • "I take donezil and it isn’t helping. I am told by several people including my husband that I repeat myself"
How many prior treatments have patients received?
1100.0%