Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr R F Riemersma-van der Lek

ORCID ID

Contact details

Netherlands Institute for Brain Research
Meibergdreef 33
Amsterdam
1105 AZ
Netherlands
+31 (0)20 566 5488
r.riemersma@nih.knaw.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZonMw no: 28-3003; NTR83

Study information

Scientific title

Acronym

Study hypothesis

A large proportion of the demented elderly show fragmented sleep-wake patterns and disturbed circadian rhythms. It appears that the amplitude of the circadian rhythms is attenuated with age, with an exaggerated decline in demented elderly. Decreased input of entraining stimuli, due to diminished stimulation by environmental light and by lower levels of the pineal hormone melatonin to the SupraChiasmatic Nucleus (SCN), the pacemaker of the circadian timing system, might contribute to these disturbances.

So far hopeful results have been found for light and melatonin in relatively small groups of patients. We now want to test the effect in a large group of patients to be able to differentiate the effects according to different subject related co-variables and to test the combination of light and melatonin.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised, placebo-controlled, parallel group, single blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Dementia, dementia symptoms

Intervention

Ceiling mounted indirect bright light (1000 lux in gaze direction) or ceiling mounted placebo light (300 lux in gaze direction), six homes in each condition. Furthermore, all participants were randomised to melatonin (2.5 mg) or placebo, daily administered one hour before bedtime.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Before starting the supplementation of light and melatonin all subjects were tested for their rest-activity rhythm by actometry, 24-hour salivary melatonin and cortisol levels were measured as was the 24-hour ear temperature. Neuropsychological assessment was done to test cognitive abilities and dementia severity and caregivers were asked about mood, behaviour, sleep and abilities in activities of daily living of the subjects.

All these measures are again tested six weeks after the start of the change in light and the supplementation of melatonin, to test the relatively short-term effects on changes in rest-activity, rhythmicity of endogenous melatonin, cortisol and temperature rhythm and alterations in mood and behaviour. The long-term effects are tested every six months after the start of light and melatonin as long as a subject participates in the study with a maximum of 3.5 years.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/06/1999

Overall trial end date

01/04/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Demented elderly, living in the assisted care facilities of 12 different homes for the elderly in different places in the Netherlands.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

189

Participant exclusion criteria

Does not comply with the above inclusion criteria

Recruitment start date

01/06/1999

Recruitment end date

01/04/2003

Locations

Countries of recruitment

Netherlands

Trial participating centre

Netherlands Institute for Brain Research
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Netherlands Institute for Brain Research (The Netherlands)

Sponsor details

Meibergdreef 33
Amsterdam
1105 AZ
Netherlands

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Hersenstichting Nederland (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Foundation Reserves Voormalige Vrijwillige Ziekenfondsverzekering (RVVZ) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Japan Foundation for Aging and Health (Japan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Foundation 'De Drie Lichten' (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Cambridge Neurotechnology (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Braun (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Philips (The Netherlands)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/18544724

Publication citations

  1. Results

    Riemersma-van der Lek RF, Swaab DF, Twisk J, Hol EM, Hoogendijk WJ, Van Someren EJ, Effect of bright light and melatonin on cognitive and noncognitive function in elderly residents of group care facilities: a randomized controlled trial., JAMA, 2008, 299, 22, 2642-2655, doi: 10.1001/jama.299.22.2642.

Editorial Notes