scholarly journals The impact of a nutritional intervention in prodromal Alzheimer’s disease: The LipiDiDiet clinical trial

2020 ◽  
Vol 16 (S10) ◽  
Author(s):  
Tobias Hartmann ◽  
Alina Solomon ◽  
Pieter Jelle Visser ◽  
Suzanne B Hendrix ◽  
Kaj Blennow ◽  
...  
Author(s):  
S. Walter ◽  
T.B. Clanton ◽  
O.G. Langford ◽  
M.S. Rafii ◽  
E.J. Shaffer ◽  
...  

BACKGROUND: The Alzheimer Prevention Trials (APT) Webstudy is the first stage in establishing a Trial-ready Cohort for Preclinical and Prodromal Alzheimer’s disease (TRC-PAD). This paper describes recruitment approaches for the APT Webstudy. Objectives: To remotely enroll a cohort of individuals into a web-based longitudinal observational study. Participants are followed quarterly with brief cognitive and functional assessments, and referred to Sites for in-clinic testing and biomarker confirmation prior to enrolling in the Trial-ready Cohort (TRC). Design: Participants are referred to the APT Webstudy from existing registries of individuals interested in brain health and Alzheimer’s disease research, as well as through central and site recruitment efforts. The study team utilizes Urchin Tracking Modules (UTM) codes to better understand the impact of electronic recruitment methods. Setting: A remotely enrolled online study. Participants: Volunteers who are at least 50 years old and interested in Alzheimer’s research. Measurements: Demographics and recruitment source of participant where measured by UTM. Results: 30,650 participants consented to the APT Webstudy as of April 2020, with 69.7% resulting from referrals from online registries. Emails sent by the registry to participants were the most effective means of recruitment. Participants are distributed across the US, and the demographics of the APT Webstudy reflect the referral registries, with 73.1% female, 85.0% highly educated, and 92.5% Caucasian. Conclusions: We have demonstrated the feasibility of enrolling a remote web-based study utilizing existing registries as a primary referral source. The next priority of the study team is to engage in recruitment initiatives that will improve the diversity of the cohort, towards the goal of clinical trials that better represent the US population.


Author(s):  
F. McDougall ◽  
C. Edgar ◽  
M. Mertes ◽  
P. Delmar ◽  
P. Fontoura ◽  
...  

BACKGROUND: The Clinical Dementia Rating–Sum of Boxes (CDR-SB) has been proposed as a primary outcome for use in prodromal AD trials. However, the psychometric properties of this, and of other commonly used measures, have not been well-established in this patient population. OBJECTIVE: To describe the psychometric properties of commonly used efficacy measures in a clinical trial of prodromal AD. SETTING: Data were gathered as part of a two-year clinical trial. PARTICIPANTS: Patients had biomarker confirmed prodromal AD. MEASUREMENTS: Clinical Dementia Rating (CDR), Functional Activities Questionnaire (FAQ), Alzheimer’s Disease Assessment Scale – Cognition Subscale 11 and 13 (ADAS-Cog), Mini Mental State Exam (MMSE), and Free and Cued Selective Reminding Test (FCSRT-IR [words]). Assessments were conducted at least every 24 weeks. RESULTS: For the CDR-SB, test-retest reliability was good (intra-class correlation coefficient [ICC]=0.83); internal consistency was 0.65 at baseline but above 0.8 at later assessments. Relationships between the CDR-SB and other measures were as expected (higher correlations with more closely related constructs), and the CDR-SB differentiated between patients with different severities of dementia (-2.9 points difference between CDR-Global Score 0.5 and 1, P<.0001). Floor and ceiling effects on the CDR-SB total score were minimal; however, at baseline there were ceiling effects in the personal care domain. Further detail is provided on the psychometric properties of ADAS-Cog, MMSE, FCSRT-IR and FAQ in this population. CONCLUSION: The psychometric properties of the CDR-SB are adequate in prodromal AD and continued use is warranted in clinical trials. However, there remains scope for improvement in the assessment of functional constructs and development of novel measures should continue.


2016 ◽  
Vol 108 ◽  
pp. 128-135 ◽  
Author(s):  
Stefan J. Teipel ◽  
Enrica Cavedo ◽  
Michel J. Grothe ◽  
Simone Lista ◽  
Samantha Galluzzi ◽  
...  

2000 ◽  
Vol 48 (3) ◽  
pp. 268-274 ◽  
Author(s):  
Richard Shikiar ◽  
Annabelle Shakespeare ◽  
Pierre-Philippe Sagnier ◽  
David Wilkinson ◽  
Ian McKeith ◽  
...  

2017 ◽  
Vol 13 (7) ◽  
pp. P1198
Author(s):  
Charlotta Thunborg ◽  
Shireen Sindi ◽  
Gerd Faxen ◽  
Thomas Storskog ◽  
Hilkka Soininen ◽  
...  

2015 ◽  
Vol 44 (4) ◽  
pp. 1157-1169 ◽  
Author(s):  
John M. Nolan ◽  
Ekaterina Loskutova ◽  
Alan Howard ◽  
Riona Mulcahy ◽  
Rachel Moran ◽  
...  

Author(s):  
Hilkka Soininen ◽  
Alina Solomon ◽  
Pieter Jelle Visser ◽  
Suzanne B Hendrix ◽  
Kaj Blennow ◽  
...  

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