Repeated Transcranial Magnetic Stimulation for Improving Cognition in Alzheimer Disease: Protocol for an Interim Analysis of a Randomized Controlled Trial.
Alzheimer disease
double blind
interim analysis, treatment efficacy, repetitive transcranial magnetic stimulation
placebo controlled
randomized
treatment
Journal
JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504
Informations de publication
Date de publication:
09 Aug 2021
09 Aug 2021
Historique:
received:
11
06
2021
accepted:
17
06
2021
revised:
16
06
2021
entrez:
12
8
2021
pubmed:
13
8
2021
medline:
13
8
2021
Statut:
epublish
Résumé
Many clinical trials investigating treatment efficacy require an interim analysis. Recently we have been running a large, multisite, randomized, placebo-controlled, double-blind clinical trial investigating the effect of repetitive transcranial magnetic stimulation (rTMS) treatment for improving or stabilizing the cognition of patients diagnosed with Alzheimer disease. The objectives of this paper are to report on recruitment, adherence, and adverse events (AEs) to date, and to describe in detail the protocol for interim analysis of the clinical trial data. The protocol will investigate whether the trial is likely to reach its objectives if continued to the planned maximum sample size. The specific requirements of the analytic protocol are to (1) ensure the double-blind nature of the data while doing the analysis, (2) estimate the predictive probabilities of success (PPoSs), (3) estimate the numbers needed to treat, (4) re-estimate the initial required sample size. The initial estimate of sample size was 208. The interim analysis will be based on 150 patients who will be enrolled in the study and finish at least 8 weeks of the study. Our protocol for interim analysis, at the very first stage, is to determine the response rate for each participant to the treatment (either sham or active), while ensuring the double-blind nature of the data. The blinded data will be analyzed by a statistician to investigate the treatment efficacy. We will use Bayesian PPoS to predict the success rate and determine whether the study should continue. The enrollment has been slowed significantly due to the COVID-19 pandemic and lockdown. Nevertheless, so far 133 participants have been enrolled, while 22 of these have been withdrawn or dropped out for various reasons. In general, rTMS has been found tolerable with no serious AE. Only 2 patients dropped out of the study due to their intolerability to rTMS pulses. Overall, the study with the same protocol is going as expected with no serious AE or any major protocol deviation. ClinicalTrials.gov NCT02908815; https://clinicaltrials.gov/ct2/show/NCT02908815. DERR1-10.2196/31183.
Sections du résumé
BACKGROUND
BACKGROUND
Many clinical trials investigating treatment efficacy require an interim analysis. Recently we have been running a large, multisite, randomized, placebo-controlled, double-blind clinical trial investigating the effect of repetitive transcranial magnetic stimulation (rTMS) treatment for improving or stabilizing the cognition of patients diagnosed with Alzheimer disease.
OBJECTIVE
OBJECTIVE
The objectives of this paper are to report on recruitment, adherence, and adverse events (AEs) to date, and to describe in detail the protocol for interim analysis of the clinical trial data. The protocol will investigate whether the trial is likely to reach its objectives if continued to the planned maximum sample size.
METHODS
METHODS
The specific requirements of the analytic protocol are to (1) ensure the double-blind nature of the data while doing the analysis, (2) estimate the predictive probabilities of success (PPoSs), (3) estimate the numbers needed to treat, (4) re-estimate the initial required sample size. The initial estimate of sample size was 208. The interim analysis will be based on 150 patients who will be enrolled in the study and finish at least 8 weeks of the study. Our protocol for interim analysis, at the very first stage, is to determine the response rate for each participant to the treatment (either sham or active), while ensuring the double-blind nature of the data. The blinded data will be analyzed by a statistician to investigate the treatment efficacy. We will use Bayesian PPoS to predict the success rate and determine whether the study should continue.
RESULTS
RESULTS
The enrollment has been slowed significantly due to the COVID-19 pandemic and lockdown. Nevertheless, so far 133 participants have been enrolled, while 22 of these have been withdrawn or dropped out for various reasons. In general, rTMS has been found tolerable with no serious AE. Only 2 patients dropped out of the study due to their intolerability to rTMS pulses.
CONCLUSIONS
CONCLUSIONS
Overall, the study with the same protocol is going as expected with no serious AE or any major protocol deviation.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT02908815; https://clinicaltrials.gov/ct2/show/NCT02908815.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
UNASSIGNED
DERR1-10.2196/31183.
Identifiants
pubmed: 34383681
pii: v10i8e31183
doi: 10.2196/31183
pmc: PMC8386362
doi:
Banques de données
ClinicalTrials.gov
['NCT02908815']
Types de publication
Journal Article
Langues
eng
Pagination
e31183Informations de copyright
©Zahra Moussavi, Lisa Koski, Paul B Fitzgerald, Colleen Millikin, Brian Lithgow, Mohammad Jafari-Jozani, Xikui Wang. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 09.08.2021.
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