There are many clinical trials in the prevention of dementia worldwide.

“Questions remain
 about the best type 
 of intervention and 
 the best time to 
intervene”

There are trials that have aimed to capture cognitive change or incident dementia outcomes.

Current research strongly suggests that multifactorial intervention trials and trials that include exercise interventions are likely to prevent the development of dementia.

However, questions remain about the best type of intervention and the best time to intervene.

Researchers are working hard to answer these questions.

Researchers are invited to submit examples of clinical trials to add to those listed below by completing the form [here.] Note the terms and conditions for inclusion on the IRNDP website.

Multifactorial intervention trials with less than 1 year follow up and/or less than 100 participants

A randomised controlled trial to enhance cognitive function in older adults.
Reference info: Poelke G, Kramer AF, Castro C, Middleton LE, Yaffe K. The Mental Activity and eXercise (MAX) trial: a randomized controlled trial to enhance cognitive function in older adults. JAMA Intern Med. 2013 May 13;173(9):797-804. doi: 10.1001/jamainternmed.2013.189. PubMed PMID: 23545598.
Area intervened: mental activity and/or physical activity
Outcome measured: cognitive function (composite score)
Trial registry info: NCT00522899
Pubmed link: https://www.ncbi.nlm.nih.gov/pubmed/23545598
A pilot randomised controlled trial of a behaviour change intervention to promote healthy ageing and reduce risk of dementia in later life.
Reference info: Clare L, Nelis SM, Jones IR, Hindle JV, Thom JM, Nixon JA, Cooney J, Jones CL, Tudor Edwards R, Whitaker CJ. The Agewell trial: a pilot randomised controlled trial of a behaviour change intervention to promote healthy ageing and reduce risk of dementia in later life. BMC Psychiatry. 2015 Feb 19;15:25. doi: 10.1186/s12888-015-0402-4. PubMed PMID: 25880911; PubMed Central PMCID: PMC4337106.
Area intervened: goal setting: physical, cognitive activity, physical health/diet, social engagement
Outcome measured: cognitive function
Trial registry info: ISRCTN30080637
Pubmed link: https://www.ncbi.nlm.nih.gov/pubmed/25880911

Multifactorial intervention trials reporting on cognitive function and dementia outcomes

Acronym: SU.FOL.OM3
Reference info: Andreeva VA, Kesse-Guyot E, Barberger-Gateau P, Fezeu L, Hercberg S, Galan P. Cognitive function after supplementation with B vitamins and long-chain omega-3 fatty acids: ancillary findings from the SU.FOL.OM3 randomized trial. Am J Clin Nutr. 2011 Jul;94(1):278-86. doi: 10.3945/ajcn.110.006320. Epub 2011 May 18. PubMed PMID: 21593490.
Area intervened: dietary: B vitamins and omega-3 fatty acid supplementation
Outcome measured: cognitive function
Trial registry info: ISRCTN41926726
Pubmed link: https://www.ncbi.nlm.nih.gov/pubmed/21593490
Acronym: MAPT
Reference info: Andrieu S, Guyonnet S, Coley N, Cantet C, Bonnefoy M, Bordes S, Bories L, Cufi MN, Dantoine T, Dartigues JF, et al. Effect of long-term omega 3 polyunsaturated fatty acid supplementation with or without multidomain intervention on cognitive function in elderly adults with memory complaints (MAPT): a randomised, placebo-controlled trial. Lancet Neurol. 2017 May;16(5):377-389. doi: 10.1016/S1474-4422(17)30040-6. Epub 2017 Mar 27. PubMed PMID: 28359749.
Area intervened: cognitive training, physical activity, nutrition, preventative consultations, omega 3 polyunsaturated fatty acids
Outcome measured: cognitive function
Trial registry info: NCT00672685
Pubmed link: https://www.ncbi.nlm.nih.gov/pubmed/28359749
Acronym: SMART
Reference info: Fiatarone Singh MA, Gates N, Saigal N, Wilson GC, Meiklejohn J, Brodaty H, Wen W, Singh N, Baune BT, Suo C, Baker MK, Foroughi N, Wang Y, Sachdev PS, Valenzuela M. The Study of Mental and Resistance Training (SMART) study—resistance training and/or cognitive training in mild cognitive impairment: a randomized, double-blind, double-sham controlled trial. J Am Med Dir Assoc. 2014 Dec;15(12):873-80. doi: 10.1016/j.jamda.2014.09.010. Epub 2014 Oct 23. PubMed PMID: 25444575.
Area intervened: physical training plus cognitive training
Outcome measured: cognitive function
Trial registry info: ANZCTR Reference No. 83075, X08-0064
Pubmed link: https://www.ncbi.nlm.nih.gov/pubmed/25444575
Acronym:
Reference info: Ihle-Hansen H, Thommessen B, Fagerland MW, Øksengård AR, Wyller TB, Engedal K, Fure B. Multifactorial vascular risk factor intervention to prevent cognitive impairment after stroke and TIA: a 12-month randomized controlled trial. Int J Stroke. 2014 Oct;9(7):932-8. doi: 10.1111/j.1747-4949.2012.00928.x. Epub 2012 Dec 4. PubMed PMID: 23205666.
Area intervened: intensive vascular risk intervention including with pharmacological treatment, healthy weight and diet, smoking and alcohol
Outcome measured: cognitive function, dementia
Trial registry info: NCT00506818.
Pubmed link: https://www.ncbi.nlm.nih.gov/pubmed/23205666
Acronym:
Reference info: Lee KS, Lee Y, Back JH, Son SJ, Choi SH, Chung YK, Lim KY, Noh JS, Koh SH, Oh BH, Hong CH. Effects of a multidomain lifestyle modification on cognitive function in older adults: an eighteen-month community-based cluster randomized controlled trial. Psychother Psychosom. 2014;83(5):270-8. doi: 10.1159/000360820. Epub 2014 Aug 6. PubMed PMID: 25116574.
Area intervened: prize-based contingency management: PASCAL (physical activity, antismoking, social activity, cognitive activity, alcohol in moderation, healthy weight/healthy diet)
Outcome measured: cognitive function
Trial registry info:
Pubmed link: https://www.ncbi.nlm.nih.gov/pubmed/25116574
Acronym: ASPIS
Reference info: Matz K, Teuschl Y, Firlinger B, Dachenhausen A, Keindl M, Seyfang L, Tuomilehto J, Brainin M; ASPIS Study Group.. Multidomain Lifestyle Interventions for the Prevention of Cognitive Decline After Ischemic Stroke: Randomized Trial. Stroke. 2015 Oct;46(10):2874-80. doi: 10.1161/STROKEAHA.115.009992. Epub 2015 Sep 15. PubMed PMID: 26374482.
And
Teuschl Y, Matz K, Firlinger B, Dachenhausen A, Tuomilehto J, Brainin M; ASPIS Study Group.. Preventive effects of multiple domain interventions on lifestyle and risk factor changes in stroke survivors: Evidence from a two-year randomized trial. Int J Stroke. 2017 Jan 1:1747493017702662. doi: 10.1177/1747493017702662. [Epub ahead of print] PubMed PMID: 28355960.
Area intervened: physical activity; weight loss management; dietary goals; smoking cessation; vascular risk monitoring including compliance with pharmacological treatment for vascular risk.
Outcome measured: cognitive function
Trial registry info: NCT01109836
Pubmed link: https://www.ncbi.nlm.nih.gov/pubmed/26374482
Acronym: PreDIVA
Reference info: Moll van Charante EP, Richard E, Eurelings LS, van Dalen JW, Ligthart SA, van Bussel EF, Hoevenaar-Blom MP, Vermeulen M, van Gool WA. Effectiveness of a 6-year multidomain vascular care intervention to prevent dementia (preDIVA): a cluster-randomised controlled trial. Lancet. 2016 Aug 20;388(10046):797-805. doi: 10.1016/S0140-6736(16)30950-3. Epub 2016 Jul 26. PubMed PMID: 27474376.
Area intervened: smoking; diet; physical activity; weight; vascular risk monitoring including treatment for high blood pressure and high cholesterol
Outcome measured: dementia
Trial registry info: ISRCTN29711771.
Pubmed link: https://www.ncbi.nlm.nih.gov/pubmed/27474376
Acronym: FINGER
Reference info: Ngandu T, Lehtisalo J, Solomon A, Levälahti E, Ahtiluoto S, Antikainen R, Bäckman L, Hänninen T, Jula A, Laatikainen T, Lindström J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12. PubMed PMID: 25771249.
Area intervened: diet; physical activity; cognitive training; vascular risk monitoring including treatment for high blood pressure and high cholesterol
Outcome measured: cognitive function
Trial registry info: NCT01041989.
Pubmed link: https://www.ncbi.nlm.nih.gov/pubmed/25771249

Terms and conditions

The recommendations, views or findings expressed in studies, trials or articles are expressly those of the authors. Such recommendations, views or findings do not represent the recommendations, views or findings of the International Research Network on Dementia Prevention (IRNDP), its Leadership Committee or Independent Advisory Group or any collaborating institutions. IRNDP accepts no responsibility for the accuracy or content, or liability in respect of studies submitted to it.