Verified
Monoclonal AntibodiesDonanemab for Alzheimer's Disease
Coram CVS/Specialty Infusion Services - Houston, Houston, TX
Targeting 2 different conditionsDonanemab +1 morePhase 3RecruitingResearch Sponsored by Eli Lilly and CompanyEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Are you between the ages of 65-80?
Are you able and willing to undergo a MRI?
Must not have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upbaseline, up to week 182
Awards & highlights
Pivotal Trial
Study Summary
This trial will test a new drug, donanemab, for safety and effectiveness in people with early Alzheimer's disease.
Eligible Conditions
- Alzheimer's Disease
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You should not have Alzheimer's disease or any form of dementia.
Select...
You can only participate in this study if you are not already taking part in another research study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, up to week 182
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to week 182
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Nootropic Agents
Secondary outcome measures
Change from Baseline in Behavioral Pattern Separation-Object test (BPS-O)
Change from Baseline in CDR-Sum of Boxes (CDR-SB)
Change from Baseline in Category Fluency
+9 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 administered intravenously (IV)
Group II: PlaceboPlacebo Group1 Intervention
Placebo is administered intravenously
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
3,171,239 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
391,988 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.
Has Donanemab received official government sanction for medical use?
"Donanemab has received a score of 3 for safety. This is due to the fact that it is a Phase 3 trial, which means that there is evidence supporting its efficacy as well as data from multiple rounds of testing affirming its safety."
Answered by AI
Are there comparable treatments to Donanemab that have undergone clinical trials?
"At the moment, there are four ongoing clinical trials studying donanemab. Three of those studies are in phase three. Although most of the trials for donanemab are taking place in Milford, Ohio, there are a total of 684 locations running these studies."
Answered by AI
Are people still being accepted into the program?
"The latest information from clinicaltrials.gov does show that this trial is still enrolling patients. The initial posting was on 8/27/2021, with the most recent update being 11/10/2022. There are 3300 positions open across 100 different medical facilities."
Answered by AI
How many people can join this research project?
"3300 participants are required to successfully run this clinical trial. The sponsor, Eli Lilly and Company, has selected different medical sites across the country to help with recruitment. For example, Option Care - Sacramento in Sacramento, California and Care Access - Beverly Hills in Beverly Hills, Texas will both be participating."
Answered by AI
Are there many locations where this research project is taking place in town?
"Currently, there are 100 clinical trial sites operating across the nation, with locations in cities such as Sacramento, Beverly Hills, and Houston."
Answered by AI
For this particular test, are senior citizens welcome?
"This particular study is for patients aged between 65 and 80 years old. Out of the 557 clinical trials for patients over 65, this one is just 1/23rds."
Answered by AI
Do we have any other examples to compare this too?
"Donanemab has a short clinical history, with the first trial being conducted in 2020. This initial study was sponsored by Eli Lilly and Company. After this 1800-person Phase 1 study, Donanemab received approval for further testing. Currently, there are 4 active trials involving 334 cities across 9 nations."
Answered by AI
What are the Participant Inclusion Criteria for this research project?
"The eligibility criteria for this study include being 65-80 years old and having a diagnosis of Alzheimer's disease. The clinical trial is looking to enroll 3300 total patients."
Answered by AI
Who else is applying?
What state do they live in?
Florida
North Carolina
Illinois
Other
How old are they?
18 - 65
65+
What site did they apply to?
Valley Clinical Trials, Inc.
Accellacare - Winston-Salem
Accellacare - DuPage
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
2
1
0
Why did patients apply to this trial?
I have memory issues. Want to help r research. Am former research nurse. Family history of Alzheimer’s.
Patient
I would like to help other people.
Patient
What questions have other patients asked about this trial?
When can I start? When and where will it take place? How long does the screening take? What is involved?
Patient
How long do screening visits take? Who is the ideal candidate for this trial?
Patient
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Phone Call
Most responsive sites:
- Tilda Research - USAL 45: < 24 hours
- Accellacare - DuPage: < 48 hours
- Accellacare - Winston-Salem: < 48 hours