The Lifestyle Intervention in memory clinics of General and academic Hospitals Trial (LIGHT): Rationale and study design of a randomized controlled trial to reduce modifiable dementia risk

V van Gils; L Waterink; S C P M Wimmers; J G M Jelsma; M E de Vugt; R Handels; S A M Sikkes; W M van der Flier; K Deckers; M D Zwan; S Köhler; N Janssen

doi:10.1186/s13195-025-01947-9

The Lifestyle Intervention in memory clinics of General and academic Hospitals Trial (LIGHT): Rationale and study design of a randomized controlled trial to reduce modifiable dementia risk

V van Gils
, L Waterink
, S C P M Wimmers
, J G M Jelsma
, M E de Vugt
, R Handels
, S A M Sikkes
, W M van der Flier
, K Deckers
, M D Zwan
, S Köhler
, N Janssen

Research output: Contribution to Journal › Article › Academic › peer-review

Abstract

INTRODUCTION: Dementia risk reduction through lifestyle modification has much potential but is not yet implemented in routine clinical care. Currently, there are no preventive interventions available for memory clinic patients. Therefore, the aim of The Lifestyle Intervention in the memory clinics of General and academic Hospitals Trial (LIGHT) is to examine the (cost)effectiveness of a multidomain intervention combining lifestyle coaching with risk self-management for patients with subjective cognitive decline (SCD) and mild cognitive impairment (MCI).

METHODS: LIGHT is a 1-year multi-center randomized controlled trial for dementia risk reduction by improving brain health through lifestyle modifications in memory clinic patients without dementia. Starting early 2025, the trial aims to include 300 older adults (≥ 50 years) with SCD or MCI, with presence of ≥ 2 modifiable dementia risk factors, recruited via the memory clinics of Dutch hospitals. Participants are randomized 1:1 to either the intervention group or control group. The intervention consists of three components: (1) three individual sessions with a certified lifestyle coach to set and work on personal goals, (2) vouchers for access to brain-healthy services from local providers, and (3) access to an online self-management platform (www.breinzorg.nl) providing psychoeducation on dementia risk reduction through lifestyle. The control group receives general health advice. The primary outcome is 1-year change in modifiable dementia risk captured by the LIfestyle for BRAin Health 2 (LIBRA2) index consisting of coronary heart disease, diabetes, hypercholesterolemia, hypertension, depression, obesity, smoking, high physical activity, and chronic kidney disease, high alcohol intake, high cognitive activity, healthy diet, hearing impairment, sleep disturbances, and social participation. Secondary outcomes include cognitive functioning, health-related quality of life, activities of daily living, self-efficacy, care use, as well as change in individual risk factors.

CONCLUSION: LIGHT will provide insight into the implementation and (cost-)effectiveness of a lifestyle intervention for indicated prevention in a memory clinic setting.

TRIAL REGISTRATION: Clinicaltrials.gov: NCT06832761 (date 2025-02-18), OMON: 57,198.

Original language	English
Article number	31
Pages (from-to)	31
Journal	Alzheimer's Research & Therapy
Volume	18
Issue number	1
Early online date	8 Jan 2026
DOIs	https://doi.org/10.1186/s13195-025-01947-9
Publication status	E-pub ahead of print - 8 Jan 2026

Bibliographical note

Funding

RH received outside this study consulting fees in the past 36 months from Lilly Nederland and from the Institute for Medical Technology Assessment (paid to institution). MV received outside this study funding in the past 36 months from ZonMW, Gieskes-Strijbisfonds, Alzheimer Onderzoeksfonds Limburg, Health~Holland, Topsector Life Sciences & Health and Stichting Alzheimer Nederland (paid to institution). SS received outside this study funding in the past 36 months from ZonMW, Health~Holland, Topsector Life Sciens & Health, Innovative Health Initiative Joint Undertaking (IHI JU), NWO and JPND (paid to the institution). SS provided consultancy services for Nationale Nederlanden Ventures, Prothena Biosciences, Aribio Co LTD, Cogstate LTD (paid to institution). Research programs of WF have been funded by ZonMW, NWO, EU-JPND, EU-IHI, Alzheimer Nederland, Hersenstichting CardioVascular Onderzoek Nederland, Health~Holland, Topsector Life Sciences & Health, stichting Dioraphte, Noaber foundation, Pieter Houbolt Fonds, Gieskes-Strijbis fonds, stichting Equilibrio, Edwin Bouw fonds, Pasman stichting, Philips, Biogen MA Inc, Novartis-NL, Life-MI, AVID, Roche BV, Eli-Lilly-NL, Fujifilm, Eisai, Combinostics. As of 1-11-2025, WF is executive director at Alzheimer Nederland, Amersfoort the Netherlands. Before 1-11-2025, research programs of Wiesje van der Flier have been funded by ZonMW, NWO, EU-JPND, EU-IHI, Alzheimer Nederland, Hersenstichting CardioVascular Onderzoek Nederland, Health~Holland, Topsector Life Sciences & Health, stichting Dioraphte, Noaber foundation, Pieter Houbolt Fonds, Gieskes-Strijbis fonds, stichting Equilibrio, Edwin Bouw fonds, Pasman stichting, Philips, Biogen MA Inc, Novartis-NL, Life-MI, AVID, Roche BV, Eli-Lilly-NL, Fujifilm, Eisai, Combinostics. WF is recipient of ABOARD, which is a public-private partnership receiving funding from ZonMW (#73305095007) and Health~Holland, Topsector Life Sciences & Health (PPP-allowance; #LSHM20106). Before 1-11-2025, WF has been an invited speaker at Biogen MA Inc, Danone, Eisai, WebMD Neurology (Medscape), NovoNordisk, Springer Healthcare, European Brain Council. WF has been consultant to Oxford Health Policy Forum CIC, Roche, Biogen MA Inc, Eisai, Eli-Lilly, Owkin France, Nationale Nederlanden Ventures. WF has participated in advisory boards of Biogen MA Inc, Roche, and Eli Lilly. All funding is paid to her institution. 2024-2025, WF has been member of the steering committee of phase 3 EVOKE/EVOKE+ studies (NovoNordisk). In 2025, WF has been member of the steering committee op phase 3 Trontinemab study (Roche). All funding has been paid to Amsterdam UMC. WF was associate editor of Alzheimer, Research & Therapy in 2020/2021. WF was associate editor at Brain 2021-2025. WF is chair of the Scientific Leadership Group of InRAD. WF is member of Supervisory Board (Raad van Toezicht) Trimbos Instituut. MZ received outside this study funding from ZonMw‐Memorabel (project no 73305095003), Alzheimer Nederland, Hersenstichting (Dutch Brain Foundation) and Amsterdam Neuroscience; and is trial site coordinator of sponsor-initiated studies with AviadoBio and TheriniBio (all paid to institution). All other authors have nothing to disclose. This study is fully funded by ZonMw – Leefstijl in de Zorg (10930012310012).

Funders	Funder number
Hersenstichting CardioVascular Onderzoek Nederland
EU-IHI
Pieter Houbolt Fonds
Alzheimer Nederland
Topsector Life Sciences & Health, stichting Dioraphte
Gieskes-Strijbis Fonds
Noaber Foundation
Dutch Brain Foundation
Topsector Life Sciences & Health
NWO
EU-JPND
Health~Holland
ZonMw
ZonMw – Leefstijl in de Zorg	10930012310012
Roche BV	73305095007, 1-11-2025
ZonMw‐Memorabel	73305095003

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https://pmc.ncbi.nlm.nih.gov/articles/PMC12882484/

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van Gils, V., Waterink, L., Wimmers, S. C. P. M., Jelsma, J. G. M., de Vugt, M. E., Handels, R., Sikkes, S. A. M., van der Flier, W. M., Deckers, K., Zwan, M. D., Köhler, S., & Janssen, N. (2026). The Lifestyle Intervention in memory clinics of General and academic Hospitals Trial (LIGHT): Rationale and study design of a randomized controlled trial to reduce modifiable dementia risk. Alzheimer's Research & Therapy, 18(1), 31. Article 31. Advance online publication. https://doi.org/10.1186/s13195-025-01947-9

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van Gils, V, Waterink, L, Wimmers, SCPM, Jelsma, JGM, de Vugt, ME, Handels, R, Sikkes, SAM, van der Flier, WM, Deckers, K, Zwan, MD, Köhler, S & Janssen, N 2026, 'The Lifestyle Intervention in memory clinics of General and academic Hospitals Trial (LIGHT): Rationale and study design of a randomized controlled trial to reduce modifiable dementia risk', Alzheimer's Research & Therapy, vol. 18, no. 1, 31, pp. 31. https://doi.org/10.1186/s13195-025-01947-9

The Lifestyle Intervention in memory clinics of General and academic Hospitals Trial (LIGHT): Rationale and study design of a randomized controlled trial to reduce modifiable dementia risk. / van Gils, V; Waterink, L; Wimmers, S C P M et al.
In: Alzheimer's Research & Therapy, Vol. 18, No. 1, 31, 12.2026, p. 31.

Research output: Contribution to Journal › Article › Academic › peer-review

TY - JOUR

T1 - The Lifestyle Intervention in memory clinics of General and academic Hospitals Trial (LIGHT)

T2 - Rationale and study design of a randomized controlled trial to reduce modifiable dementia risk

AU - van Gils, V

AU - Waterink, L

AU - Wimmers, S C P M

AU - Jelsma, J G M

AU - de Vugt, M E

AU - Handels, R

AU - Sikkes, S A M

AU - van der Flier, W M

AU - Deckers, K

AU - Zwan, M D

AU - Köhler, S

AU - Janssen, N

PY - 2026/1/8

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N2 - INTRODUCTION: Dementia risk reduction through lifestyle modification has much potential but is not yet implemented in routine clinical care. Currently, there are no preventive interventions available for memory clinic patients. Therefore, the aim of The Lifestyle Intervention in the memory clinics of General and academic Hospitals Trial (LIGHT) is to examine the (cost)effectiveness of a multidomain intervention combining lifestyle coaching with risk self-management for patients with subjective cognitive decline (SCD) and mild cognitive impairment (MCI).METHODS: LIGHT is a 1-year multi-center randomized controlled trial for dementia risk reduction by improving brain health through lifestyle modifications in memory clinic patients without dementia. Starting early 2025, the trial aims to include 300 older adults (≥ 50 years) with SCD or MCI, with presence of ≥ 2 modifiable dementia risk factors, recruited via the memory clinics of Dutch hospitals. Participants are randomized 1:1 to either the intervention group or control group. The intervention consists of three components: (1) three individual sessions with a certified lifestyle coach to set and work on personal goals, (2) vouchers for access to brain-healthy services from local providers, and (3) access to an online self-management platform (www.breinzorg.nl) providing psychoeducation on dementia risk reduction through lifestyle. The control group receives general health advice. The primary outcome is 1-year change in modifiable dementia risk captured by the LIfestyle for BRAin Health 2 (LIBRA2) index consisting of coronary heart disease, diabetes, hypercholesterolemia, hypertension, depression, obesity, smoking, high physical activity, and chronic kidney disease, high alcohol intake, high cognitive activity, healthy diet, hearing impairment, sleep disturbances, and social participation. Secondary outcomes include cognitive functioning, health-related quality of life, activities of daily living, self-efficacy, care use, as well as change in individual risk factors.CONCLUSION: LIGHT will provide insight into the implementation and (cost-)effectiveness of a lifestyle intervention for indicated prevention in a memory clinic setting.TRIAL REGISTRATION: Clinicaltrials.gov: NCT06832761 (date 2025-02-18), OMON: 57,198.

AB - INTRODUCTION: Dementia risk reduction through lifestyle modification has much potential but is not yet implemented in routine clinical care. Currently, there are no preventive interventions available for memory clinic patients. Therefore, the aim of The Lifestyle Intervention in the memory clinics of General and academic Hospitals Trial (LIGHT) is to examine the (cost)effectiveness of a multidomain intervention combining lifestyle coaching with risk self-management for patients with subjective cognitive decline (SCD) and mild cognitive impairment (MCI).METHODS: LIGHT is a 1-year multi-center randomized controlled trial for dementia risk reduction by improving brain health through lifestyle modifications in memory clinic patients without dementia. Starting early 2025, the trial aims to include 300 older adults (≥ 50 years) with SCD or MCI, with presence of ≥ 2 modifiable dementia risk factors, recruited via the memory clinics of Dutch hospitals. Participants are randomized 1:1 to either the intervention group or control group. The intervention consists of three components: (1) three individual sessions with a certified lifestyle coach to set and work on personal goals, (2) vouchers for access to brain-healthy services from local providers, and (3) access to an online self-management platform (www.breinzorg.nl) providing psychoeducation on dementia risk reduction through lifestyle. The control group receives general health advice. The primary outcome is 1-year change in modifiable dementia risk captured by the LIfestyle for BRAin Health 2 (LIBRA2) index consisting of coronary heart disease, diabetes, hypercholesterolemia, hypertension, depression, obesity, smoking, high physical activity, and chronic kidney disease, high alcohol intake, high cognitive activity, healthy diet, hearing impairment, sleep disturbances, and social participation. Secondary outcomes include cognitive functioning, health-related quality of life, activities of daily living, self-efficacy, care use, as well as change in individual risk factors.CONCLUSION: LIGHT will provide insight into the implementation and (cost-)effectiveness of a lifestyle intervention for indicated prevention in a memory clinic setting.TRIAL REGISTRATION: Clinicaltrials.gov: NCT06832761 (date 2025-02-18), OMON: 57,198.

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DO - 10.1186/s13195-025-01947-9

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van Gils V, Waterink L, Wimmers SCPM, Jelsma JGM, de Vugt ME, Handels R et al. The Lifestyle Intervention in memory clinics of General and academic Hospitals Trial (LIGHT): Rationale and study design of a randomized controlled trial to reduce modifiable dementia risk. Alzheimer's Research & Therapy. 2026 Dec;18(1):31. 31. Epub 2026 Jan 8. doi: 10.1186/s13195-025-01947-9

The Lifestyle Intervention in memory clinics of General and academic Hospitals Trial (LIGHT): Rationale and study design of a randomized controlled trial to reduce modifiable dementia risk

Abstract

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Funding

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