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Monoclonal Antibodies

Anti-Inflammatory Drugs for Mild Alzheimer's Disease

Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Male or female, age ≥ 45 years and ≤ 90 years at the time of signing the informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 30 days post last dose
Awards & highlights

Study Summary

This trial will test the effects of anti-inflammatory drugs on cognition in early Alzheimer's patients, as well as safety and tolerability of the drugs.

Who is the study for?
This trial is for men and women aged 45-90 with mild cognitive impairment or mild Alzheimer's, confirmed by specific criteria including amyloid and tau presence. Participants must have a caregiver and meet certain cognitive test score requirements. Those with other neurological conditions, major cerebrovascular disease, or using inflammation-modulating treatments are excluded.Check my eligibility
What is being tested?
The study tests the effectiveness of Canakinumab, an anti-inflammatory agent, against a placebo in improving cognition for early Alzheimer's patients. It also assesses safety and effects on both brain and body inflammation.See study design
What are the potential side effects?
While not specified here, anti-inflammatory agents like Canakinumab may cause side effects such as infections due to immune suppression, allergic reactions at the injection site, digestive issues, blood disorders, and potential heart risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with early-stage Alzheimer's disease.
Select...
I am between 45 and 90 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 30 days post last dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 30 days post last dose for reporting.

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 in cognition as measured by the Neuropsychological Test Battery (NTB) total score
Secondary outcome measures
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 microglia activation as measured by Positron-Emission Tomography-Translocator Protein 18kDa - microglia activation
+3 more

Side effects data

From 2017 Phase 3 trial • 203 Patients • NCT02059291
50%
Bronchitis
50%
Diarrhoea
50%
Conjunctivitis
50%
Gastroenteritis
50%
Drug eruption
25%
Teething
25%
Pyogenic granuloma
25%
Dental caries
25%
Eye allergy
25%
Gastritis
25%
Nausea
25%
Vomiting
25%
Nasopharyngitis
25%
Malaise
25%
Aspartate aminotransferase increased
25%
Tonsillitis bacterial
25%
Alanine aminotransferase increased
25%
Neutrophil count increased
25%
Pain in extremity
25%
Headache
25%
Dermatitis allergic
25%
Pyoderma gangrenosum
25%
Rash pruritic
25%
Scleritis
25%
Hyper IgD syndrome
25%
Eye pain
25%
Familial mediterranean fever
25%
Constipation
25%
Stomatitis
25%
Influenza
25%
Rhinitis
25%
Sialoadenitis
25%
Viral upper respiratory tract infection
25%
C-reactive protein increased
25%
Neutrophil count decreased
25%
Serum amyloid A protein increased
25%
White blood cell count increased
25%
Hypocalcaemia
25%
Arthralgia
25%
Back pain
25%
Somnolence
25%
Eczema
25%
Keloid scar
25%
Urticaria
25%
Aphthous ulcer
25%
Ear infection
25%
Hypophosphataemia
25%
Pancytopenia
25%
Hepatic failure
25%
Laryngitis
25%
Haemorrhoids
25%
Pyrexia
25%
Viral tonsillitis
25%
Dehydration
25%
Pain of skin
25%
Skin ulcer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Non-randomized Open Label crFMF, HIDS/MKD Patients
Randomized ACZ and Placebo TRAPS Patients - ACZ Events
Randomized ACZ and Placebo HIDS/MKD Pts - No Medication Events
Randomized ACZ and Placebo HIDS/MKD Patients - ACZ Events
Randomized ACZ and Placebo crFMF Patients - ACZ Events
Any ACZ crFMF Patients - ACZ Events
Randomized ACZ and Placebo crFMF Pts - No Medication Events
Non-randomized Open Label TRAPS Patients
Any ACZ crFMF Patients - Placebo Events
Randomized ACZ and Placebo TRAPS Patients - Placebo Events
Randomized ACZ and Placebo TRAPS Pts - No Medication Events
Any ACZ HIDS/MKD Patients - No Medication Events
Any ACZ HIDS/MKD Patients - ACZ Events
Randomized ACZ and Placebo HIDS/MKD Pts - Placebo Events
Any ACZ TRAPS Patients - Placebo Events
Any ACZ TRAPS Patients - ACZ Events
Randomized ACZ and Placebo crFMF Patients - Placebo Events
Any ACZ TRAPS Patients - no Medication Events
Any ACZ HIDS/MKD Patients - Placebo Events
Any ACZ crFMF Patients - No Medication Events

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CanakinumabExperimental Treatment1 Intervention
increasing doses of sub-cutaneous injections
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo sub-cutaneous injections
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Canakinumab
2011
Completed Phase 3
~3090

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,316 Total Patients Enrolled

Media Library

Canakinumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04795466 — Phase 2
Alzheimer's Disease Research Study Groups: Canakinumab, Placebo
Alzheimer's Disease Clinical Trial 2023: Canakinumab Highlights & Side Effects. Trial Name: NCT04795466 — Phase 2
Canakinumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04795466 — Phase 2

Frequently Asked Questions

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

Is the research still open to new participants?

"Affirmative. According to clinicaltrials.gov, this research is looking for 90 individuals across 5 locations, with the original posting on October 28th 2021 and most recent update occurring November 11th 2022."

Answered by AI

Who is able to join this trial based on the specified criteria?

"This medical trial seeks ninety individuals with alzheimer disease, aged between 45 and 90 years old. Candidates should be male or female, have a reliable caretaker to accompany them to each visit, meet the criteria of probable MCI due to AD or mild AD according to the NIA-AA standards; present CSF sampling results that confirm amyloid and tau positivity at screening phase; demonstrate Mini-Mental State Examination (MMSE) scores ranging from 20 to 24 inclusive OR MMSE score of 25 - 30 inclusively plus DSST performance 0.5 SD below normative data at screening stage as well."

Answered by AI

How many sites are administering this clinical trial?

"At present, 5 clinical trial sites are actively enrolling patients. These locations can be found in Stony Brook, Fairfax and Knoxville as well as two other places. To minimize travel requirements if you choose to participate, select the closest site to your current residence."

Answered by AI

Is this investigation the inaugural exploration of its kind?

"Presently, Canakinumab is the subject of 16 open trials conducted in 263 urban centres and 52 nations. The inaugural trial for this Novartis Pharmaceuticals-sponsored drug commenced back in 2018 with 1382 participants progressing to Phase 3 approval. Subsequently, 18363 have been concluded since then."

Answered by AI

Has the FDA issued a license for Canakinumab?

"Although there is limited data suggesting the efficacy of Canakinumab, our team at Power has assigned it a rating of 2 due to its safety profile in Phase 2 trials."

Answered by AI

To what medical conditions does Canakinumab generally provide relief?

"Canakinumab is a viable treatment for Muckle-Wells Syndrome, Active Systemic Juvenile Idiopathic Arthritis and Neonatal-Onset Multisystem Inflammatory Disease (NOMID)."

Answered by AI

Is the age limitation of this research confined to those under 25?

"According to the criteria outlined in this trial, it is necessary that participants are aged at least 45 and no older than 90."

Answered by AI

How many participants can the maximum capacity of this clinical trial accommodate?

"Affirmative. Per the data hosted on clinicaltrials.gov, this medical study is recruiting patients as of 11/11/2022 after being initially posted on 10/28/2021. The research team require 90 participants to be enrolled from 5 difference sites."

Answered by AI

Are there any studies that have evaluated the effects of Canakinumab?

"Currently, 16 studies on Canakinumab are underway with 3 trials in their final stage. The bulk of these investigations are based out of Houston, Texas but there is a total of 609 investigative sites for this medication."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
~10 spots leftby Apr 2025