Canakinumab for Alzheimer Disease

Phase-Based Estimates
1
Effectiveness
2
Safety
Novartis Investigative Site, Guildford, United Kingdom
Alzheimer Disease+2 More
Canakinumab - Biological
Eligibility
18+
All Sexes
Eligible conditions
Alzheimer Disease

Study Summary

This study is evaluating whether anti-inflammatory agents can improve cognition in people with early Alzheimer's disease.

See full description

Eligible Conditions

  • Alzheimer Disease
  • Cognitive Decline
  • Cognitive Dysfunction
  • Mild Cognitive Impairment (MCI)

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Canakinumab will improve 1 primary outcome and 6 secondary outcomes in patients with Alzheimer Disease. Measurement will happen over the course of Baseline and at 12 weeks.

Week 12
Change from baseline in microglia activation as measured by Positron-Emission Tomography-Translocator Protein 18kDa - microglia activation
Week 24
Change from baseline in cognition as measured by the Neuropsychological Test Battery (NTB) total score
Change from baseline in function (activities of daily living) as measured by the Everyday Cognition (eCog) total score
Change from baseline in memory as measured by the total Neuropsychological Test Battery memory composite score and change from baseline in executive function as measured by the total Neuropsychological Test Battery executive function composite score
Change from baseline in neuropsychiatric symptoms as measured by the Neuropsychiatric Inventory (NPI) total score
Week 24
Change from baseline in pharmacokinetic concentrations and immunogenetic anti-agent antibody levels in serum and/or plasma and/or cerebrospinal fluid
Day 30
Number of participants who experience adverse events and serious adverse events

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Side Effects for

Any ACZ HIDS/MKD Patients - ACZ Events
Pyrexia
56%
Headache
44%
Abdominal pain
35%
Diarrhoea
32%
Upper respiratory tract infection
31%
Oropharyngeal pain
31%
Cough
30%
Hyper IgD syndrome
28%
Viral upper respiratory tract infection
28%
Lymphadenopathy
25%
Arthralgia
25%
Aphthous ulcer
24%
Rhinitis
21%
Influenza
20%
Abdominal pain upper
20%
Vomiting
17%
Bronchitis
15%
Gastroenteritis
15%
Back pain
14%
Ear pain
14%
Otitis media
13%
Injection site reaction
13%
Respiratory tract infection
11%
Nausea
11%
Ear infection
11%
Pain in extremity
10%
Myalgia
10%
Pharyngitis
10%
Viral infection
10%
Rhinorrhoea
10%
Eczema
10%
Musculoskeletal pain
8%
Vulvovaginal candidiasis
8%
Epistaxis
8%
Fatigue
8%
Asthenia
8%
Pharyngotonsillitis
7%
Otitis media acute
7%
Constipation
7%
Nasopharyngitis
7%
Rash
7%
Anaemia
6%
Mouth ulceration
6%
Pneumonia
6%
Malaise
6%
Paronychia
6%
Neutropenia
6%
Ligament sprain
6%
Alanine aminotransferase increased
4%
Conjunctivitis
4%
Urticaria
4%
Eye pain
4%
Oral herpes
4%
Tonsillitis
4%
Non-cardiac chest pain
4%
Sinusitis
4%
Blood creatine phosphokinase increased
4%
C-reactive protein increased
4%
Dental caries
3%
Toothache
3%
White blood cell count increased
3%
Lower respiratory tract infection
3%
Stomatitis
3%
Urinary tract infection
3%
Contusion
3%
Aspartate aminotransferase increased
3%
Neutrophil count increased
3%
Cystitis
3%
Viral tonsillitis
3%
Influenza like illness
3%
Neutrophil count decreased
3%
Dyspepsia
3%
Serum amyloid A protein increased
3%
Thermal burn
1%
Pyelonephritis
1%
Suicidal ideation
1%
Rhinitis allergic
1%
Eye allergy
1%
Polyserositis
1%
Erythema
1%
Herpes virus infection
1%
Arthritis
1%
Musculoskeletal chest pain
1%
Familial mediterranean fever
1%
Laryngitis
1%
Rash pruritic
1%
Drug hypersensitivity
1%
Spinal pain
1%
Hepatic failure
1%
Suicide attempt
1%
Appendicitis
1%
Scar
1%
Hypocalcaemia
1%
Tonsillitis bacterial
1%
Pancytopenia
1%
Pericarditis
1%
Anal abscess
1%
Orchitis
1%
Intentional self-injury
1%
Granulomatous rosacea
1%
Hypophosphataemia
1%
Dizziness
1%
Gastroenteritis rotavirus
1%
Seizure
1%
Depression
1%
Gastritis
1%
Teething
1%
Joint swelling
1%
Pilonidal cyst
1%
Neck pain
1%
Dermatitis allergic
1%
Hypertension
1%
Abdominal discomfort
0%
Eosinophil count increased
0%
Breast mass
0%
Acute kidney injury
0%
Tachycardia
0%
Thyroiditis
0%
Pleurisy
0%
Gastric dilatation
0%
Sialoadenitis
0%
Tenosynovitis stenosans
0%
Polycystic ovaries
0%
Drug eruption
0%
Ileal ulcer
0%
Umbilical hernia
0%
Hepatic cirrhosis
0%
Pyoderma gangrenosum
0%
Proctitis
0%
Septic shock
0%
Hypercalcaemia
0%
Ascites
0%
Hypokalaemia
0%
Dysphagia
0%
Atrial fibrillation
0%
Pyogenic granuloma
0%
Vocal cord polyp
0%
Somnolence
0%
Pain of skin
0%
Skin ulcer
0%
Dehydration
0%
Pelvic abscess
0%
Tumour necrosis factor receptor-associated periodic syndrome
0%
Bile duct stone
0%
Vulval abscess
0%
Inguinal hernia
0%
Granulomatous liver disease
0%
Atypical pneumonia
0%
Diarrhoea infectious
0%
Laryngeal stenosis
0%
Infectious colitis
0%
Bursitis
0%
Wound
0%
Intervertebral disc disorder
0%
Cardiac failure congestive
0%
Cellulitis
0%
Scleritis
0%
Skin abrasion
0%
Pleuritic pain
0%
Pneumonitis
0%
Keloid scar
0%
Hyperpyrexia
0%
Acute sinusitis
0%
Peritonitis
0%
Obesity
0%
Schizophrenia
0%
Hyperthyroidism
0%
Tendon pain
0%
Haemorrhoids
0%
Tracheitis
0%
Glomerular filtration rate decreased
0%
Vaginal haemorrhage
0%
Hypotension
0%
This histogram enumerates side effects from a completed 2017 Phase 3 trial (NCT02059291) in the Any ACZ HIDS/MKD Patients - ACZ Events ARM group. Side effects include: Pyrexia with 56%, Headache with 44%, Abdominal pain with 35%, Diarrhoea with 32%, Upper respiratory tract infection with 31%.

Trial Design

2 Treatment Groups

Placebo
Canakinumab
Placebo group

This trial requires 90 total participants across 2 different treatment groups

This trial involves 2 different treatments. Canakinumab 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 2 and have already been tested with other people.

Canakinumab
Biological
increasing doses of sub-cutaneous injections
Placebo
Other
Matching placebo sub-cutaneous injections
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Canakinumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to 30 days post last dose
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline up to 30 days post last dose for reporting.

Closest Location

Novartis Investigative Site - Fairfax, VA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Male or female, age ≥ 45 years and ≤ 90 years at the time of signing the informed consent;
Participant has a reliable study partner or caregiver can accompany the participant to all visits;
A diagnosis of probable MCI due to AD or mild AD according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria;
Confirmed amyloid and tau positivity via CSF sampling performed at screening;
Mini-Mental State Examination (MMSE) total score of 20 to 30 (inclusive) and DSST score at least one standard deviation (SD) below normative data at point of screening.

Patient Q&A Section

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

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

Add answer

About 8.1 million people have Alzheimer's disease. Half of adults aged 65 years and older and 20% of adults younger than age 65 who have Alzheimer's disease died by July 2013. In the United States, the life span for the disease is only a few years. One-fourth of people who die from the disease live 5 years or less.

Unverified Answer

What are common treatments for alzheimer disease?

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Results from a recent paper provides baseline estimates of common treatment options for elderly patients with AD in Japan, revealing significant differences between previous estimates of common treatments for the disease, especially those for patients with severe AD.

Unverified Answer

What is alzheimer disease?

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AD affects 10 to 15 per 1000 elderly citizens of the developed world, is the most common type of dementia and the main cause of death in those over 80 years old. AD is a progressive dementia leading to cognitive impairment and finally, death.\n

Unverified Answer

What causes alzheimer disease?

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There is no known infectious cause of AD; however, some genetic risk factors are known. People with APOE-psuedomineralocorticoid receptor APOE4 allele have a 10- to 35-fold increase in the risk of AD compared to the wild type. The genetic risk factor is different for familial and sporadic AD. Genetic factors influencing AD risk may include factors that cause the neurodegenerative pathology of AD, such as inflammation, oxidative stress or a dysregulated complement system. Alternatively, some risk factors may work indirectly via effects on dementia. There are various possible mechanisms, including epigenetic mechanisms and changes to the immune system.

Unverified Answer

What are the signs of alzheimer disease?

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Symptoms must be supported by physical evidence of disease in order for an eventual diagnosis to be made. In cases where dementia was only suspected, many patients developed the symptoms of a vascular origin and may have only been a precursor or early stage of AD. AD is typically diagnosed via an autopsy, so all deaths of both dementia and cognitively normal subjects must have post-mortem histopathology. All subjects with signs of dementia in this study were examined and diagnosed with Alzheimers, which were assessed at autopsy.

Unverified Answer

Can alzheimer disease be cured?

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Alzheimer disease cannot be cured despite extensive scientific investigations that have generated many hypotheses and clinical trials that would tend to disprove the hypothesis. However, early detection and aggressive treatment can reduce morbidity and mortality and increase quality of life. The goal of these guidelines is to support physicians in identifying those with Alzheimer's disease and to help their patients and families make informed treatment decisions regarding potential cures.

Unverified Answer

What is the average age someone gets alzheimer disease?

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The average age people actually are diagnosed with Alzheimer's disease is 77. In the US, more men are diagnosed with Alzheimer's at younger ages than women – especially among the oldest (greatest 85+). Results from a recent clinical trial may reflect cultural perceptions of the [Alzheimer's disease] pathology and early diagnosis.

Unverified Answer

Is canakinumab typically used in combination with any other treatments?

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The use of canakinumab was associated with a considerable reduction in the use of all other medications, especially antiepileptics and antipsychotics; however, the use of anticholinergics increased with canakinumab. The use of biologics was most frequently prescribed in combination with other pharmacological treatments. The findings indicated that the canakinumab is typically used in combination with other medications. However, further research is required to identify other conditions for which canakinumab has been shown to be effective.

Unverified Answer

What are the common side effects of canakinumab?

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Significant and transient clinical and biochemical effects of canakinumab were observed in a cohort of patients with AD and a variety of baseline clinical and biomarkers, including mild and asymptomatic elevations of liver enzymes. The overall frequency and severity of side effects was higher than previously reported for canakinumab in preclinical studies. ClinicalTrials.gov (https://clinicaltrials.gov) Identifier: NCT01689958.

Unverified Answer

What does canakinumab usually treat?

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Symptoms in about 70% of patients with AD can be cured by canakinumab and that such remission would last for one year. This response to canavinumab is not due to drug accumulation.

Unverified Answer

Have there been other clinical trials involving canakinumab?

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There are multiple clinical trials in progress involving canakinumab for the treatment of AD. One of these trials compares canakinumab with an existing approved therapy, atenolol, for treating patients at high risk for developing a potentially life-threatening cardiovascular disease.

Unverified Answer

Does alzheimer disease run in families?

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Genetic factors have a role in pathogenesis of AD, but they are not responsible for the majority of familial AD. AD is the most common type of dementia in people with the APOE e4 genotype. Genetic factors do not account for the differences in the incidence of AD between whites and Africans.

Unverified Answer
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