scholarly journals Multimodal preventive trial for Alzheimer’s disease (MIND‐AD MINI ): Pilot trial progress and results

2021 ◽  
Vol 17 (S10) ◽  
Author(s):  
Miia Kivipelto ◽  
Shireen Sindi ◽  
Charlotta Thunborg ◽  
Anna Rosenberg ◽  
Nicola Coley ◽  
...  
CNS Drugs ◽  
2014 ◽  
Vol 28 (12) ◽  
pp. 1185-1189 ◽  
Author(s):  
Michael H. Rosenbloom ◽  
Terry R. Barclay ◽  
Maria Pyle ◽  
Brian L. Owens ◽  
Amanda B. Cagan ◽  
...  

Author(s):  
N. Costa ◽  
M. Mounié ◽  
A. Pagès ◽  
H. Derumeaux ◽  
T. Rapp ◽  
...  

BACKGROUND: To date, no curative treatment is available for Alzheimer’s disease (AD). Therefore, efforts should focus on prevention strategies to improve the efficiency of healthcare systems. Objective: Our aim was to assess the cost-effectiveness of three preventive strategies for AD compared to a placebo. Design: The Multidomain Alzheimer Preventive Trial (MAPT) study was a multicenter, randomized, placebo-controlled superiority trial with four parallel groups, including three intervention groups (one group with Multidomain Intervention (MI) plus a placebo, one group with Polyunsaturated Fatty Acids (PFA), one group with a combination of PFA and MI) and one placebo group. Setting: Participants were recruited and included in 13 memory centers in France and Monaco. Participants: Community-dwelling subject aged 70 years and older were followed during 3 years. Interventions: We used data from the MAPT study which aims to test the efficacy of a MI along PFA, the MI plus a placebo, PFA alone, or a placebo alone. Measurement: Direct medical and non-medical costs were calculated from a payer’s perspective during the 3 years of follow-up. The base case incremental Cost-Effectiveness Ratio (ICER) represents the cost per improved cognitive Z-score point. Sensitivity analyses were performed using different interpretation of the effectiveness criteria. Results: Analyses were conducted on 1,525 participants. The ICER at year 3 that compares the MI + PFA and the MI alone to the placebo amounted to €21,443 and €21,543 respectively, per improved Z score point. PFA alone amounted to €111,720 per improved Z score point. Conclusion: Our study shows that ICERS of PFA combined with MI and MI alone amounted to €21,443 and €21,543 respectively per improved Z score point compared to the placebo and are below the WTP of €50,000 while the ICER of PFA alone amounted to €111,720 per improved Z score point. This information may help decision makers and serve as a basis for the implementation of a lifetime decision analytic model.


2019 ◽  
Vol 15 ◽  
pp. 100419 ◽  
Author(s):  
Amelia Gulliver ◽  
Georgia Pike ◽  
Michelle Banfield ◽  
Alyssa R. Morse ◽  
Natasha Katruss ◽  
...  

2013 ◽  
Vol 38 (1) ◽  
pp. 111-120 ◽  
Author(s):  
Lynne Shinto ◽  
Joseph Quinn ◽  
Thomas Montine ◽  
Hiroko H. Dodge ◽  
William Woodward ◽  
...  

2017 ◽  
Vol 13 (7) ◽  
pp. P940 ◽  
Author(s):  
Brent Forester ◽  
Caitlin Romano ◽  
William Quayle ◽  
Joanna Georgakas ◽  
Paul B. Rosenberg

2022 ◽  
Author(s):  
Anna Maria Matziorinis ◽  
Birthe Kristin Flo ◽  
Stavros Skouras ◽  
Kathrine Dahle ◽  
Tobba Therkildsen Sudmann ◽  
...  

Abstract Background: The Alzheimer’s and Music Therapy (ALMUTH) study is the first randomised controlled trial (RCT) design with 12 months of active non-pharmacological therapy (NPT) implementing music therapy (MT) and physical activity (PA) for participants with Alzheimer’s disease (AD). The aim of the present article is to retrospectively examine the inclusion of mild-to-moderate Alzheimer’s Disease patients into the main ALMUTH study protocol and to determine if continued inclusion of AD patients is warranted. Methods: The randomised pilot trial was conducted as a parallel three-arm RCT, reflecting the experimental design of the ALMUTH study. The trial was conducted in Bergen, Norway and randomisation (1:1:1) was performed by an external researcher. The study was open label and the experimental design features two active NPTs: MT and PA, and a passive control (no intervention, CON) in Norwegian speaking patients with AD who still live at home and could provide informed consent. Sessions were offered one time per week (up to 90 minutes) up to 40 sessions over the period of 12 months. Baseline and follow-up tests included a full neuropsychological test battery and three magnetic resonance imaging (MRI) measurements (structural, functional, and diffusion weighted imaging). Feasibility outcomes were assessed and were determined as feasible if they met the target criteria. Results: 18 participants with a diagnosis of mild-to-moderate AD were screened, randomised, and tested at baseline and after a 12-month follow-up interval. Participants were divided into three groups: MT (n=6), PA (n=6), and CON (n=6). Results of the study revealed that the ALMUTH protocol in patients with AD is not feasible. Adherence to protocol was poor (50% attended sessions), the presence of 50% attrition rates, 50% retention rates, insufficient and costly recruitment, issues with study fidelity, and many issues raised by staff. Recruitment status is still ongoing and the main study has been expanded to include milder forms of memory impairment. No adverse events were reported by the patients or their caregivers. Conclusions: The pilot trial was not deemed feasible in patients exclusively with AD. To mitigate this, the ALMUTH study has expanded the recruitment criteria to include participants with milder forms of memory impairment (pre-AD) in addition to expanding the neuropsychological test battery. The ALMUTH study is currently ongoing. Trial Registration: Norsk Forskningsråd (NFR) funded. Regional Committees for Medical and Health Research Ethics (REC-WEST: reference number 2018/206). ClinicalTrials.gov: NCT03444181 (registered retrospectively 23 February 2018, https://clinicaltrials.gov/ct2/show/NCT03444181).


Author(s):  
I. Choi ◽  
H. La Monica ◽  
S.L. Naismith ◽  
A. Rahmanovic ◽  
L. Mowszowski ◽  
...  

Communicating personal Alzheimer’s disease risk profiles based on validated risk algorithms may improve public knowledge about risk reduction, and initiate action. This proof of concept pilot trial aimed to test whether this is feasible and potentially effective and/or harmful. Older at-risk adults (N=24) were provided with their personal Alzheimer’s disease risk profile online, which contained information on their personal risk level, scores and tailored recommendations to manage modifiable risk factors. After receiving the risk profile, participants were significantly more accurate in identifying risk and protective factors, and revised their perceived risk to be lower than their initial estimate. There was no apparent harm seen in psychological distress or dementia-related worry. This shows preliminary support for the feasibility of delivering personal dementia risk profiles to low risk, help-seeking older adults in an online format. A definitive trial examining behavioural outcomes and testing in groups with higher risk profiles is now warranted.


2011 ◽  
Vol 7 ◽  
pp. S419-S419 ◽  
Author(s):  
Julien Delrieu ◽  
Pierre Payoux ◽  
Anne Hitzel ◽  
Sophie Peiffer ◽  
Gabor Abellan Van Kan ◽  
...  

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