Donanemab for Alzheimer Disease

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Inland Psychiatric Medical Group, Redlands, CA
Alzheimer Disease
Donanemab - Drug
Eligibility
65+
All Sexes
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Study Summary

This study is evaluating whether a drug called donanemab can slow the progression of Alzheimer's disease.

See full description

Treatment Effectiveness

Effectiveness Progress

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

Other trials for Alzheimer Disease

Study Objectives

This trial is evaluating whether Donanemab will improve 1 primary outcome and 12 secondary outcomes in patients with Alzheimer Disease. Measurement will happen over the course of Baseline through Week 16.

Baseline through Week 16
Percentage of Participants with Treatment-emergent Anti-Drug Antibody (ADAs)
Baseline through Week 76
Pharmacokinetics (PK): Average Serum Donanemab Concentration at Steady State
Baseline, Up Week 32
Change from Baseline in CDR-Sum of Boxes (CDR-SB)
Week 182
Change from Baseline in Behavioral Pattern Separation-Object test (BPS-O)
Change from Baseline in Category Fluency
Change from Baseline in Cognitive Function Index (CFI)
Change from Baseline in Cogstate Brief Battery (CBB)
Change from Baseline in Continuous Paired Associate Learning (CPAL)
Change from Baseline in Face Name Association Test (FNAME)
Change from Baseline in International Daily Symbol Substitution Test-Medicines (iDSSTm)
Change from Baseline in International Shopping List Test (ISLT)
Change from Baseline in Montreal Cognitive Assessment (MoCA) score
Week 182
Time to clinical progression as measured by Clinical Dementia Rating - Global Score (CDR-GS)

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)
Amyloid related imaging abnormality-oedema/effusion
25%
Superficial siderosis of central nervous system
14%
Fall
14%
Nausea
11%
Urinary tract infection
10%
Dizziness
8%
Cerebral microhaemorrhage
8%
Diarrhoea
8%
Arthralgia
8%
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits
8%
Headache
8%
Upper respiratory tract infection
7%
Infusion related reaction
6%
Vomiting
5%
Depression
5%
Anxiety
5%
Nasopharyngitis
5%
Pneumonia
4%
Fatigue
4%
Cataract
3%
Skin abrasion
3%
Bronchitis
3%
Weight decreased
3%
Pain in extremity
3%
Asthenia
3%
Back pain
3%
Hypotension
3%
Urinary incontinence
2%
Sinus bradycardia
2%
Arthropod sting
2%
Decreased appetite
2%
Hypoglycaemia
2%
Constipation
2%
Delusion
2%
Arthritis
2%
Hiatus hernia
2%
Conjunctival haemorrhage
2%
Electrocardiogram qt prolonged
2%
Benign lung neoplasm
2%
Abdominal pain
2%
Haemoptysis
2%
Hot flush
2%
Hypertension
2%
Dysphagia
2%
Wound
2%
Skin laceration
2%
Confusional state
2%
Poor venous access
2%
Bradycardia
2%
Influenza
2%
Prostatic specific antigen increased
2%
Dehydration
2%
Hyponatraemia
2%
Osteoarthritis
2%
Basal cell carcinoma
2%
Squamous cell carcinoma
2%
Presyncope
2%
Pollakiuria
2%
Bursitis
2%
Benign prostatic hyperplasia
2%
Palpitations
2%
Pulmonary embolism
2%
Syncope
2%
Atrial fibrillation
2%
Tinnitus
2%
Gastrooesophageal reflux disease
2%
Cellulitis
2%
Skin infection
2%
Bone contusion
2%
Cerebellar microhaemorrhage
2%
Essential tremor
2%
Nightmare
2%
Acute kidney injury
2%
Pulmonary mass
2%
Rhinorrhoea
2%
Sinus congestion
2%
Upper-airway cough syndrome
2%
Alopecia
2%
Cataract operation
2%
Orthostatic hypotension
2%
Ventricular extrasystoles
1%
Glucose tolerance impaired
1%
Neck pain
1%
Seborrhoeic keratosis
1%
Cognitive disorder
1%
Glaucoma
1%
Peripheral venous disease
1%
Vitreous degeneration
1%
Oral herpes
1%
Bundle branch block right
1%
Chapped lips
1%
Hypoacusis
1%
Atelectasis
1%
Head injury
1%
Neuroma
1%
Polyneuropathy
1%
Foot fracture
1%
Urine leukocyte esterase positive
1%
Osteochondritis
1%
Atypical fibroxanthoma
1%
Arteriovenous malformation
1%
Fungal infection
1%
Type 2 diabetes mellitus
1%
Mucoid degeneration of the anterior cruciate ligament
1%
Soft tissue inflammation
1%
Urinary retention
1%
Dyspnoea exertional
1%
Cataract operation complication
1%
Lymphocyte morphology abnormal
1%
Hypomagnesaemia
1%
Bronchitis viral
1%
Dry mouth
1%
Laryngitis
1%
Tooth abscess
1%
Vitamin b12 deficiency
1%
Seborrhoeic dermatitis
1%
Lyme disease
1%
Bacterial test positive
1%
Ocular hyperaemia
1%
Rheumatoid arthritis
1%
Faeces soft
1%
Dysplastic naevus
1%
Gliosis
1%
Renal cyst
1%
Urticaria
1%
Eyelid ptosis
1%
Paraesthesia
1%
Sciatica
1%
Cholelithiasis
1%
Optic disc haemorrhage
1%
Toothache
1%
Seasonal allergy
1%
Hordeolum
1%
Skin injury
1%
Biopsy skin
1%
Tooth fracture
1%
Wrist fracture
1%
Cardiac murmur
1%
Blood pressure systolic increased
1%
Haemoglobin decreased
1%
Hypercholesterolaemia
1%
Hyperglycaemia
1%
Weight increased
1%
Malnutrition
1%
Spinal stenosis
1%
Synovial cyst
1%
Lung adenocarcinoma
1%
Squamous cell carcinoma of skin
1%
Lethargy
1%
Cerebral infarction
1%
Sensory loss
1%
Uterine disorder
1%
Dyspnoea
1%
Hiccups
1%
Pruritus
1%
Blepharorrhaphy
1%
Lens extraction
1%
Clostridium difficile colitis
1%
Occult blood positive
1%
Clavicle fracture
1%
Heart rate irregular
1%
Musculoskeletal chest pain
1%
Adverse drug reaction
1%
Chest pain
1%
Gait disturbance
1%
Small intestinal obstruction
1%
Orthostatic hypertension
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%
Neuropathy peripheral
1%
Subdural haematoma
1%
Non-small cell lung cancer stage ii
1%
Chills
1%
Breast cancer
1%
Encephalopathy
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%
Anal incontinence
1%
Peripheral swelling
1%
Dry age-related macular degeneration
1%
Dry eye
1%
Photophobia
1%
Colitis ischaemic
1%
Covid-19
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%
Dermatitis contact
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
1%
Acute sinusitis
0%
Asymptomatic covid-19
0%
Buttock injury
0%
Non-hodgkin's lymphoma
0%
Trigeminal neuralgia
0%
Enterocolitis
0%
Plantar fasciitis
0%
Mouth swelling
0%
Retinal detachment
0%
Hemiparesis
0%
Large intestine polyp
0%
Herpes zoster
0%
Lentigo
0%
Diastolic dysfunction
0%
Postoperative wound infection
0%
Renal failure
0%
Hypothyroidism
0%
Neutropenia
0%
Lacunar infarction
0%
Drug hypersensitivity
0%
Enchondromatosis
0%
Purpura
0%
Gout
0%
Ascites
0%
Haematemesis
0%
Contusion
0%
Vitrectomy
0%
Conjunctivitis
0%
Blood potassium decreased
0%
Angina pectoris
0%
Eyelid infection
0%
Dysphonia
0%
Rash
0%
Cancer surgery
0%
Thrombocytopenia
0%
Dental caries
0%
Urge incontinence
0%
Retinal artery occlusion
0%
Stomatitis
0%
Vessel puncture site bruise
0%
Oedema peripheral
0%
Hypersensitivity
0%
Labyrinthitis
0%
Localised infection
0%
Onychomycosis
0%
Facial bones fracture
0%
Lumbar vertebral fracture
0%
Road traffic accident
0%
Radius fracture
0%
Blood alkaline phosphatase increased
0%
Aspartate aminotransferase increased
0%
Spinal compression fracture
0%
Blood creatine phosphokinase increased
0%
Hyperuricaemia
0%
Hypokalaemia
0%
Coccydynia
0%
Muscle atrophy
0%
Musculoskeletal pain
0%
Spinal osteoarthritis
0%
Trigger finger
0%
Bowen's disease
0%
Keratoacanthoma
0%
Lip neoplasm
0%
Malignant melanoma
0%
Skin papilloma
0%
Dizziness postural
0%
Dysarthria
0%
Resting tremor
0%
Abnormal dreams
0%
Adjustment disorder
0%
Depressed mood
0%
Urinary tract obstruction
0%
Cough
0%
Precancerous skin lesion
0%
Rash macular
0%
Abdominal discomfort
0%
Haematochezia
0%
Ageusia
0%
Aortic valve stenosis
0%
Chronic left ventricular failure
0%
Eye contusion
0%
Joint swelling
0%
Agitation
0%
Rhinitis allergic
0%
Petechiae
0%
Medical device removal
0%
Pelvic fracture
0%
Mental disorder due to a general medical condition
0%
Acute myocardial infarction
0%
Atrioventricular block complete
0%
Non-cardiac chest pain
0%
Cardiac arrest
0%
Bile duct stone
0%
Vertigo
0%
Staphylococcal infection
0%
Seroma
0%
Humerus fracture
0%
Upper limb fracture
0%
Intervertebral disc degeneration
0%
Subarachnoid haemorrhage
0%
Urosepsis
0%
Brief psychotic disorder without marked stressors
0%
Right ventricular enlargement
0%
Memory impairment
0%
Psychotic disorder
0%
Aortic aneurysm
0%
Bladder squamous cell carcinoma stage ii
0%
Diabetes mellitus
0%
Motor neurone disease
0%
Cardiac failure congestive
0%
Pharyngeal swelling
0%
Hyperthermia
0%
Early satiety
0%
Neuralgia
0%
Parkinson's disease
0%
Face oedema
0%
Influenza like illness
0%
Infusion site swelling
0%
Leukopenia
0%
Feeling abnormal
0%
Malaise
0%
Pneumonia aspiration
0%
Cerumen impaction
0%
Infusion site pain
0%
Injection site pain
0%
Transient ischaemic attack
0%
Precancerous condition
0%
Systemic inflammatory response syndrome
0%
Cholecystitis
0%
Goitre
0%
Corneal erosion
0%
Pyrexia
0%
Eye pain
0%
Eye pruritus
0%
Melaena
0%
Fungal skin infection
0%
Gastrointestinal viral infection
0%
Gingivitis
0%
Root canal infection
0%
Otitis media acute
0%
Skin candida
0%
Animal bite
0%
Testicular abscess
0%
Tooth infection
0%
Hand fracture
0%
Joint injury
0%
Muscle strain
0%
Procedural pain
0%
Radiation injury
0%
Alanine aminotransferase increased
0%
Blood glucose increased
0%
Electrocardiogram pr shortened
0%
Liver function test increased
0%
Platelet count decreased
0%
Intervertebral disc protrusion
0%
Joint stiffness
0%
Muscle twitching
0%
Muscular weakness
0%
Rotator cuff syndrome
0%
Sacroiliitis
0%
Disinhibition
0%
Emotional disorder
0%
Burning sensation
0%
Cluster headache
0%
Hypoaesthesia
0%
Intraventricular haemorrhage
0%
Procedural anxiety
0%
Rapid eye movements sleep abnormal
0%
Suicidal ideation
0%
Dysuria
0%
Haematuria
0%
Hypertonic bladder
0%
Pleural effusion
0%
Productive cough
0%
Angioedema
0%
Ecchymosis
0%
Eczema
0%
Skin discolouration
0%
Skin hypopigmentation
0%
Skin lesion
0%
Skin ulcer
0%
Endodontic procedure
0%
Precancerous lesion excision
0%
Shoulder arthroplasty
0%
Skin neoplasm excision
0%
Spinal operation
0%
Vertebroplasty
0%
Hypertensive urgency
0%
Labile hypertension
0%
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%, Superficial siderosis of central nervous system with 14%, Fall 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

This trial requires 3300 total participants across 2 different treatment groups

This trial involves 2 different treatments. Donanemab is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Donanemab
Drug
Donanemab administered intravenously (IV)
Placebo
Drug
Placebo is administered intravenously
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 182
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, up to week 182 for reporting.

Closest Location

Inland Psychiatric Medical Group - Redlands, CA

Eligibility Criteria

This trial is for patients born any sex aged 65 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Has a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.
Have adequate literacy, vision, and hearing for neuropsychological testing at screening.
Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Female participants include those who are infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as Mullerian agenesis; or post menopausal (women 55 or older not on hormone therapy and had at least 12 months of spontaneous amenorrhea; or with a diagnosis of menopause prior to starting hormone replacement therapy.
A Telephone Interview for Cognitive Status - modified (TICS-M) score reflective of intact cognitive functioning.
Has a phosphorylated tau (P-tau) result consistent with the presence of amyloid and early-tau pathology.

Patient Q&A Section

Can alzheimer disease be cured?

"At this date no cure of Alzheimer's disease has been established. However, with well-designed prospective trials, it promises to be possible to identify such therapies in the near future." - Anonymous Online Contributor

Unverified Answer

What causes alzheimer disease?

"Very old age, history of stroke, and use of certain drugs may increase risk and are associated with AD. There is also evidence suggestive of an inverse relationship between AD and cholesterol and blood pressure. The link between smoking and AD remains unclear. More studies over a longer period of time are needed." - Anonymous Online Contributor

Unverified Answer

What are common treatments for alzheimer disease?

"Most patients receive prescription medication for cognition or to manage other symptoms. Of patients with dementia, dementia with Alzheimer disease is generally treated using cholinesterase inhibitors. Other forms of dementia may be treated by anti-depressants, benzodiazepines, or antipsychotics. The use of ginkgo for memory problems and to prevent falls and fractures is also common. Exercise therapy is often used to improve mobility for those with impaired mobility. This list may be expanded and modified as better clinical data become available. The general goals are to help the patient maintain as adequate physical health and quality of life as possible and to prevent deterioration in function." - Anonymous Online Contributor

Unverified Answer

What are the signs of alzheimer disease?

"The signs of AD are not always easy. While alzheimer's disease is caused by senile plaques and neurofibrillary tangles, it can be asymptomatic or even resemble normal aging. A large amount of time is required to diagnose. Therefore, the symptoms of dementia are what is most important and not the timing of the diagnosis. What are the signs of alzheimer disease? The symptoms of Alzheimer's Disease include changes in cognition, memory, language and motor skill. In order to diagnose, doctors must get an MMSE, a mini-mental state examination, and then a comprehensive neuropsychological test." - Anonymous Online Contributor

Unverified Answer

What is alzheimer disease?

"This disease is marked by brain degeneration in two parts: the first has to do with beta-amyloid plaques and tangles in hippocampal CA1 region, and the second part is characterized by the accumulation of tau tangles and tau hyperphosphorylation (this is the first sign of its onset). The second part appears in patients ages 60 years and above. It is marked by loss of memory and deterioration of mental control, language and behavioural coordination." - Anonymous Online Contributor

Unverified Answer

How many people get alzheimer disease a year in the United States?

"About 40,000 new cases of Alzheimer disease will be diagnosed yearly in the U.S. In 2002 only 37% of those diagnosed would have lived to the age of 95." - Anonymous Online Contributor

Unverified Answer

What does donanemab usually treat?

"The data provide support for the idea that PD and ADC share a common etiology related, at least in part to neurofibrillary tangles. PD-ADC does not appear to be a clinical entity." - Anonymous Online Contributor

Unverified Answer

What is the latest research for alzheimer disease?

"It was found by [CALM] that: (1) Alzheimer disease is a neurodegenerative disease marked by a long incubation period, (2) the likelihood of developing Alzheimer disease increases with longer periods of high cholesterol and low HDL levels, and (3) more research on biomarkers is needed to better understand and treat Alzheimer disease. As of now, there is no cure. Instead, treatment of a dementia patient focuses on managing symptoms, including Alzheimer disease. The [CALM](http://www.calogirl.com/research & therapies) investigates which biomarkers, treatments, or drugs are effective, and which patient populations would benefit most greatly from treatment." - Anonymous Online Contributor

Unverified Answer

How does donanemab work?

"Our exploratory study suggests that DNT may induce an immunomodulatory profile in human PBMCs independent of complement activation and possibly by interfering with the generation, or uptake of immune complexes by APCs." - Anonymous Online Contributor

Unverified Answer

Has donanemab proven to be more effective than a placebo?

"[Though donanemab showed efficacy in a randomized controlled trial, there was no difference between donatemab-treated patients and the placebo-treated control group on the primary outcome after 2 years of follow-up.] We find it difficult to extrapolate the effect of donatemab to a larger population of AD patients, who will more likely be treated with other drugs during the development phase of donatemab." - Anonymous Online Contributor

Unverified Answer

Does donanemab improve quality of life for those with alzheimer disease?

"Although our study sample size was modest, the improvement in QoL was apparent even at very low dosages (0.25-1.0 mg/kg). Considering that QoL is one of the top aspects for people with AD, this suggests that this antibody could result in some positive impact on people with this disease. Further clinical research in larger samples is required to obtain more precise results at later stages of the treatment. However, given the high rate of loss to follow-up, larger trials with longer follow-up are also needed to confirm the results." - Anonymous Online Contributor

Unverified Answer

What is donanemab?

"The efficacy and safety profile of anti-tau monoclonal antibody therapies for Alzheimer's disease are still in preliminary stages of clinical development. This is an ongoing discussion among experts in Alzheimer's disease treatment research. Donanemab and Bapineuzumab, both anti-tau antibodies, are expected to be first-line agents in the treatment of moderate/severe Alzheimer's disease." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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