NCT00040378

Prevention of Alzheimer's Disease by Vitamin E and Selenium (PREADVISE)

Completed Last updated 12 March 2018

What this trial tests

trial testing alphatocopherol in Alzheimer Disease in 4,246 participants. Completed in 1 August 2016.

Timeline

1 May 2002

Primary endpoint
1 January 2014

1 August 2016

Quick facts

Lead sponsor	Frederick Schmitt
Status	Completed
Study type	OBSERVATIONAL
Enrollment	4,246
Start date	1 May 2002
Primary completion	1 January 2014
Estimated completion	1 August 2016
Sites	91 locations across United States, Canada, Puerto Rico

Drugs / interventions tested

• alphatocopherol — full drug profile →
• Selenium (SELENIUM) — full drug profile →
• Placebo replacement for vitamin E — full drug profile →
• Placebo replacement for Selenium — full drug profile →

Conditions studied

• Alzheimer Disease — all drugs for Alzheimer Disease →

Sponsor

Frederick Schmitt — full company profile →

Who can join

Adults 60 to 90, male only, with Alzheimer Disease. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• incidence of dementia (including Alzheimer's disease)
  Time frame: 7 to 12 years (depending on enrollment date)
  Participants will complete a modified Telephone Interview of Cognitive Status (TIC-S) to evaluate the onset of dementia

Sponsor's own description

The Prevention of Alzheimer's Disease by Vitamin E and Selenium (PREADVISE) prevention trial is an important addition to the Selenium and Vitamin E Cancer Prevention Trial (SELECT). As a prevention trial, PREADVISE is trying to find out if taking selenium and/or Vitamin E supplements can help to prevent memory loss and dementia such as Alzheimer's disease.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Association of Antioxidant Supplement Use and Dementia in the Prevention of Alzheimer's Disease by Vitamin E and Selenium Trial (PREADViSE).
   Kryscio RJ, Abner EL, Caban-Holt A, Lovell M, et al · · 2017 · cited 218× · PMID 28319243 · DOI 10.1001/jamaneurol.2016.5778
2. Oxidative stress in Alzheimer's disease: why did antioxidant therapy fail?
   Persson T, Popescu BO, Cedazo-Minguez A. · · 2014 · cited 196× · PMID 24669288 · DOI 10.1155/2014/427318
3. Oxidative damage in neurodegeneration: roles in the pathogenesis and progression of Alzheimer disease.
   Perluigi M, Di Domenico F, Butterfield DA. · · 2024 · cited 154× · PMID 37843394 · DOI 10.1152/physrev.00030.2022
4. Neuroprotection Against Oxidative Stress: Phytochemicals Targeting TrkB Signaling and the Nrf2-ARE Antioxidant System.
   Hannan MA, Dash R, Sohag AAM, Haque MN, et al · · 2020 · cited 128× · PMID 32714148 · DOI 10.3389/fnmol.2020.00116
5. The Link between Oxidative Stress, Mitochondrial Dysfunction and Neuroinflammation in the Pathophysiology of Alzheimer's Disease: Therapeutic Implications and Future Perspectives.
   Jurcău MC, Andronie-Cioara FL, Jurcău A, Marcu F, et al · · 2022 · cited 119× · PMID 36358538 · DOI 10.3390/antiox11112167
6. Antioxidants in Alzheimer's Disease: Current Therapeutic Significance and Future Prospects.
   Pritam P, Deka R, Bhardwaj A, Srivastava R, et al · · 2022 · cited 108× · PMID 35205079 · DOI 10.3390/biology11020212
7. The ubiquitin proteasomal system: a potential target for the management of Alzheimer's disease.
   Gadhave K, Bolshette N, Ahire A, Pardeshi R, et al · · 2016 · cited 92× · PMID 27028664 · DOI 10.1111/jcmm.12817
8. Insights into the Pathogenesis of Neurodegenerative Diseases: Focus on Mitochondrial Dysfunction and Oxidative Stress.
   Jurcau A. · · 2021 · cited 89× · PMID 34769277 · DOI 10.3390/ijms222111847