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Anti-Inflammatory Drugs for Mild Alzheimer's Disease
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2017 Phase 3 trial • 203 Patients • NCT02059291Trial Design
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Who is running the clinical trial?
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- I do not have any brain or mental health conditions that could affect my thinking or memory.I am between 45 and 90 years old.Your MMSE score is between 20 and 24.Your memory and thinking test scores need to be within a certain range during the screening.I have been diagnosed with early-stage Alzheimer's disease.You have been tested and confirmed to have abnormal levels of certain proteins in your spinal fluid.I have been diagnosed with vascular dementia.I am using a treatment aimed at changing the course of Alzheimer's disease.If a past MRI or CT scan shows signs of a serious brain blood vessel disease.You have a certain score on a memory and thinking test called the Mini-Mental State Examination (MMSE) and/or a similar test called the Digit Symbol Substitution Test (DSST).
- Group 1: Canakinumab
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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)."
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."
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."
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."
Who else is applying?
What state do they live in?
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What portion of applicants met pre-screening criteria?
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