Monoclonal Antibodies
Donanemab for Alzheimer's Disease
Parkinson's Disease and Movement Disorders, Boca Raton, FL
Donanemab +1 morePhase 3Waitlist AvailableResearch Sponsored by Eli Lilly and CompanyEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
MMSE score of 20 to 28 (inclusive) at baseline
Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upbaseline, up to week 76
Awards & highlights
Pivotal Trial
Study Summary
This trial is studying how safe and effective donanemab is in treating early Alzheimer's disease.
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
Your memory and thinking skills, as measured by a test called MMSE, should be between 20 and 28.
Select...
You or someone close to you has noticed a decline in your memory for at least 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, up to week 76
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to week 76
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline on the integrated Alzheimer's Disease Rating Scale (iADRS)
Secondary outcome measures
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)
+6 moreSide effects data
From 2021 Phase 2 trial • 272 Patients • NCT0336740325%
Amyloid related imaging abnormality-oedema/effusion
15%
Fall
14%
Superficial siderosis of central nervous system
11%
Nausea
10%
Urinary tract infection
9%
Arthralgia
8%
Diarrhoea
8%
Headache
8%
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits
8%
Cerebral microhaemorrhage
8%
Dizziness
7%
Upper respiratory tract infection
6%
Infusion related reaction
5%
Vomiting
5%
Nasopharyngitis
5%
Anxiety
5%
Depression
4%
Pneumonia
4%
Pain in extremity
4%
Fatigue
3%
Bronchitis
3%
Asthenia
3%
Weight decreased
3%
Back pain
3%
Cataract
3%
Skin abrasion
3%
Hypotension
2%
Gastrooesophageal reflux disease
2%
Hiatus hernia
2%
Skin infection
2%
Cerebellar microhaemorrhage
2%
Alopecia
2%
Dehydration
2%
Syncope
2%
Atrial fibrillation
2%
Bradycardia
2%
Tinnitus
2%
Conjunctival haemorrhage
2%
Dysphagia
2%
Arthropod sting
2%
Decreased appetite
2%
Hypoglycaemia
2%
Hyponatraemia
2%
Arthritis
2%
Osteoarthritis
2%
Basal cell carcinoma
2%
Benign lung neoplasm
2%
Delusion
2%
Acute kidney injury
2%
Sinus congestion
2%
Upper-airway cough syndrome
2%
Cataract operation
2%
Hot flush
2%
Hypertension
2%
Electrocardiogram qt prolonged
2%
Prostate cancer
2%
Pulmonary embolism
2%
Prostatic specific antigen increased
2%
Abdominal pain
2%
Anal incontinence
2%
Constipation
2%
Cellulitis
2%
Covid-19
2%
Influenza
2%
Skin laceration
2%
Wrist fracture
2%
Bursitis
2%
Squamous cell carcinoma
2%
Presyncope
2%
Confusional state
2%
Nightmare
2%
Pollakiuria
2%
Urinary incontinence
2%
Benign prostatic hyperplasia
2%
Pulmonary mass
2%
Rhinorrhoea
2%
Orthostatic hypotension
2%
Poor venous access
2%
Bone contusion
2%
Wound
2%
Essential tremor
2%
Palpitations
2%
Sinus bradycardia
2%
Haemoptysis
1%
Tachycardia
1%
Seasonal allergy
1%
Clostridium difficile colitis
1%
Vitamin b12 deficiency
1%
Tendonitis
1%
Urinary retention
1%
Tooth extraction
1%
Injection site pruritus
1%
Pyrexia
1%
Fungal infection
1%
Small intestinal obstruction
1%
Death
1%
Bacterial sepsis
1%
Covid-19 pneumonia
1%
Cervical vertebral fracture
1%
Extradural haematoma
1%
Jaw fracture
1%
Subdural haematoma
1%
Cerebrovascular accident
1%
Encephalopathy
1%
Atrial flutter
1%
Bundle branch block left
1%
Bundle branch block right
1%
Mitral valve incompetence
1%
Ventricular extrasystoles
1%
Arteriovenous malformation
1%
Hypoacusis
1%
Eyelid ptosis
1%
Optic disc haemorrhage
1%
Lower respiratory tract infection
1%
Lyme disease
1%
Chapped lips
1%
Colitis ischaemic
1%
Toothache
1%
Adverse drug reaction
1%
Chest discomfort
1%
Chest pain
1%
General physical health deterioration
1%
Tooth abscess
1%
Viral upper respiratory tract infection
1%
Arthropod bite
1%
Cataract operation complication
1%
Clavicle fracture
1%
Facial bones fracture
1%
Foot fracture
1%
Head injury
1%
Ligament sprain
1%
Limb injury
1%
Meniscus injury
1%
Rib fracture
1%
Skin injury
1%
Tendon rupture
1%
Vaccination complication
1%
Blood pressure systolic increased
1%
Creatinine renal clearance decreased
1%
Heart rate irregular
1%
Lymphocyte morphology abnormal
1%
Glucose tolerance impaired
1%
Hyperkalaemia
1%
Lactic acidosis
1%
Malnutrition
1%
Overweight
1%
Musculoskeletal chest pain
1%
Neck pain
1%
Osteochondritis
1%
Rheumatoid arthritis
1%
Spinal stenosis
1%
Synovial cyst
1%
Temporomandibular joint syndrome
1%
Atypical fibroxanthoma
1%
Dysplastic naevus
1%
Neuroma
1%
Squamous cell carcinoma of skin
1%
Balance disorder
1%
Cognitive disorder
1%
Paraesthesia
1%
Peripheral sensorimotor neuropathy
1%
Hallucination
1%
Initial insomnia
1%
Hiccups
1%
Dermatitis
1%
Dermatitis allergic
1%
Transient acantholytic dermatosis
1%
Urticaria
1%
Blepharorrhaphy
1%
Dental implantation
1%
Anaemia
1%
Bacterial test positive
1%
Biopsy skin
1%
Laryngitis
1%
Synovial rupture
1%
Mucoid degeneration of the anterior cruciate ligament
1%
Cerebral infarction
1%
Dementia alzheimer's type
1%
Polyneuropathy
1%
Sleep apnoea syndrome
1%
Dermatitis bullous
1%
Cardiac pacemaker insertion
1%
Blood pressure increased
1%
C-reactive protein increased
1%
Cardiac murmur
1%
Haemoglobin decreased
1%
Occult blood positive
1%
Sinus node dysfunction
1%
Duodenal ulcer haemorrhage
1%
Gastroenteritis
1%
Hip fracture
1%
Breast cancer
1%
Non-small cell lung cancer stage ii
1%
Drug eruption
1%
Anaemia of chronic disease
1%
Qrs axis abnormal
1%
Weight increased
1%
Dry age-related macular degeneration
1%
Lacrimation increased
1%
Ocular hyperaemia
1%
Photophobia
1%
Photopsia
1%
Visual impairment
1%
Vitreous degeneration
1%
Dry mouth
1%
Faeces soft
1%
Chills
1%
Gait disturbance
1%
Medical device site reaction
1%
Peripheral swelling
1%
Soft tissue inflammation
1%
Cholelithiasis
1%
Hordeolum
1%
Sinusitis
1%
Tooth fracture
1%
Traumatic haematoma
1%
Hypercholesterolaemia
1%
Hyperglycaemia
1%
Hypocalcaemia
1%
Facet joint syndrome
1%
Jaw disorder
1%
Joint effusion
1%
Muscle spasms
1%
Lung adenocarcinoma
1%
Drug withdrawal headache
1%
Head discomfort
1%
Lethargy
1%
Migraine
1%
Occipital neuralgia
1%
Patient elopement
1%
Sciatica
1%
Sensory loss
1%
Tremor
1%
Insomnia
1%
Irritability
1%
Glycosuria
1%
Hydronephrosis
1%
Nephrolithiasis
1%
Renal cyst
1%
Uterine disorder
1%
Atelectasis
1%
Hypoxia
1%
Oropharyngeal pain
1%
Actinic keratosis
1%
Erythema
1%
Ingrowing nail
1%
Pruritus
1%
Seborrhoeic dermatitis
1%
Skin hyperpigmentation
1%
Cardiac pacemaker replacement
1%
Cryotherapy
1%
Intraocular lens implant
1%
Lens extraction
1%
Skin cryotherapy
1%
Peripheral venous disease
1%
Bronchitis viral
1%
Seborrhoeic keratosis
1%
Neuralgia
1%
Dermatitis contact
1%
Dry eye
1%
Glaucoma
1%
Oral herpes
1%
Hypomagnesaemia
1%
Neuropathy peripheral
1%
Orthostatic hypertension
1%
Sinus arrest
1%
Sinus arrhythmia
1%
Gliosis
1%
Dyspnoea
1%
Dyspnoea exertional
100%
80%
60%
40%
20%
0%
Study treatment Arm
Donanemab Monotherapy (Donanemab-M)
Donanemab in Combination With LY3202626 (Donanemab-C)
Placebo
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DonanemabExperimental Treatment1 Intervention
Donanemab given intravenously (IV).
Group II: PlaceboPlacebo Group1 Intervention
Placebo given IV.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Donanemab
Not yet FDA approved
Find a site
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,531 Previous Clinical Trials
3,172,039 Total Patients Enrolled
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 Director
Eli Lilly and Company1,300 Previous Clinical Trials
392,788 Total Patients Enrolled
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are we able to sign up for this trial right now?
"This particular clinical trial is not currently recruiting patients. However, it was initially posted on 6/19/20 and edited as recently as 8/3/22. If you are interested in other studies, 562 clinical trials for alzheimer disease and 4 studies for Donanemab are actively searching for participants."
Answered by AI
Does this clinical trial have an age limit? If so, what is the maximum age of participants?
"The age limit for candidates eligible for this trial are between 60 to 85 years old."
Answered by AI
How many different medical facilities are running this clinical trial?
"There are 100 recruiting patients for this study such as Sensible Healthcare, LLC in Ocoee, Senior Adults Specialty Research in Austin, and Arch Clinical Trials, LLC in Saint Louis."
Answered by AI
What is the current regulatory status of Donanemab?
"Donanemab has received a 3 for safety from our team at Power. This is because it is a Phase 3 trial, and there is thus some data supporting efficacy as well as multiple rounds of data affirming safety."
Answered by AI
How many patients are currently enrolled in this trial?
"Unfortunately, this study is not enrolling patients at the moment. The listing was created on June 19th 2020 and updated as recently as August 3rd 2022. There are 562 other trials for patients with Alzheimer's disease that are still recruiting participants along with 4 clinical trials for Donanemab."
Answered by AI
Can you provide some context for this Donanemab study by detailing other research that has been conducted in the past?
"Donanemab was first studied in 2020 for its efficacy in treating Parkinson's Disease and Movement Disorders. Since then, there have been 18290 completed clinical trials worldwide. As of now, there are 4 live studies-- a significant number of which are based out of Ocoee, Texas."
Answered by AI
To whom does this study's eligibility requirements apply?
"The target population for this study are those aged 60 to 85 who have Alzheimer's disease. Out of these patients, 1800 will be enrolled. Furthermore, it is a requirement that they have a Mini-Mental State Examination (MMSE) score between 20 and 28 at the start of the trial as well as having had gradual changes in their memory function over a period of at least six months."
Answered by AI
Has a clinical trial like this been conducted before?
"There are 4 ongoing clinical trials for Donanemab in 334 cities across 9 countries. The very first study was completed in 2020 and it received Phase 3 drug approval. Since then, 18290 more trials have been completed."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
Pennsylvania
Florida
Other
How old are they?
18 - 65
65+
What site did they apply to?
ARS- Neurology and Neurodiagnostics of Alabama
Ezy Medical Research
Suncoast Neuroscience Associates
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
Why did patients apply to this trial?
I have mild memory loss. Just starting clinical trial research. I take donezil and it isn’t helping. I am told by several people including my husband that I repeat myself.
Patient
Recent research and studies