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Alzheimer's DiseaseNCT00479843

Nutritional Programme for Dementia Elderly Patient

A study testing Nutritional programme in people with Alzheimer's Disease and Dementia, run by Société des Produits Nestlé (SPN) at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main objective of this study is the improvement of the quality of life and state of health of elderly people with cognitive deterioration and their families through a weight loss prevention programme. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Alzheimer's Disease, Dementia
What is being tested?
Nutritional programme
How many people
946 participants
Where
1 siteSpain
Study dates
Jul 2005to Jul 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient has dementia according to DSM IV criteria.
  • The patient has an MMSE less than or equal to 26.
  • The patient lives in his/her home.
  • The patient is in the charge of a carer.
  • Informed consent for participation in the study by the responsible relative and, if possible, from the patient or legal guardian.

Who cannot join

  • The patient lives in an institution.
  • The patient is in a terminal situation.
  • The patient does not have a main carer.
  • Patient has a nasogastric feed.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Institut Català de l'envelliment

    Barcelona, Barcelona, 08041

Other trials in Spain

About this study

Official title: Development of a Programme to Show the Positive Effect of a Nutritional Programme on Preventing Functional and Weight Losses in Patients With Dementia

The main objective of this study is the improvement of the quality of life and state of health of elderly people with cognitive deterioration and their families through a weight loss prevention programme.

The secondary objectives are the improvement of the state of nutrition, a reduction in the use of resources and a reduction in the burden on the main carer.

Read the detailed description

Main objective The main objective of this project is the evaluation of the effectiveness of a nutrition programme in patients with Alzheimer's or other dementias. Through the Nutrition Programme the idea is to reduce functional and weight loss in elderly people with cognitive deterioration and their families.

Evaluation of the effectiveness of the intervention

-The main evaluation criteria which will allow the effectiveness of this intervention to be evaluated are the reduction in the loss of autonomy measured by the DA/IDA scale.

Secondary objectives

The secondary objectives of this study are:

  • Improvement in the patient's state of nutrition The measurement criteria which will allow the patient's nutritional state to be evaluated will be their weight, BMI and MNA.
  • Reducing the burden on carers. The Zarit scale will be used for this evaluation.
  • Evaluation of the use of healthcare and social resources. The RUD scale will be used.
  • Improvement of medical practice regarding nutrition.
  • Evaluation of the representatives of our population with regard to the participation in a programme of these characteristics evaluating.
  • Evaluation of the satisfaction of elderly people and their families in relation to the programme.
Being tested
Nutritional programme
Keywords
Alzheimer Disease, Dementia, Elderly, Nutrition, Malnutrition, Weight Loss
Medical subject headings
Alzheimer Disease, Dementia, Malnutrition, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutritional programmeBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of the effectiveness of the intervention -The main evaluation criteria which will allow the effectiveness of this intervention to be evaluated are the reduction in the loss of autonomy measured by the DA/IDA scale.

    Measured: Baseline, 6 months, 12 months

Secondary outcomes (1)

  1. -Improvement in the patient's state of nutrition -Reducing the burden on carers with the Zarit scale. -Evaluation of the use of healthcare and social resources with the RUD scale. -Improvement of medical practice regarding nutrition.

    Measured: Baseline, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2007 (estimated)
  2. Study startJul 2005
  3. Primary completionJul 2007
  4. Study completionJul 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
946 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00479843
Sponsor's protocol ID
05.19.CLI
Status last verified
Jan 2014
First submitted
25 May 2007
Last updated
24 Jan 2014
Results posted
No
Data monitoring committee
No

Publications

  • Salvà A(1) , Fernández E(2), Andrieux S(3), Schiffrin E(4), Vellas B(3), y el grupo Nutrialz. 1. Institut de l'Envelliment. Universitat Autònoma de Barcelona. 2. Service de Gerontologie Clinique. Hôpital Pourpan. Caselardit. Toulouse. France. 3. Nestle Nutrition. Vevey. Switzerland. Estado nutricional de un grupo de pacientes ambulatorios y las principales correlaciones con las variables de la valoración geriátrica: El Estudio Nutrialz.49th Congress from the spanish aging association (6-9 June 2007, Palma de Mallorca) Salvà A(1) , Fernández E(2), Andrieux S(3), Schiffrin E(4), Vellas B(3), y el grupo Nutrialz. 1. Institut de l'Envelliment. Universitat Autònoma de Barcelona. 2. Service de Gerontologie Clinique. Hôpital Pourpan. Caselardit. Toulouse. France. 3. Nestle Nutrition. Vevey. Switzerland Nutritional status for ambulatory dementia patients and its main correlation with caregivers psychosocial variables: The Nutrialz Study INTERNATIONAL ASSOCIATION OF GERONTOLOGY AND GERIATRICS VI EUROPEAN CONGRESS (5-8 July 2007, Saint Petersburg).

  • Roque M, Salva A, Vellas B. Malnutrition in community-dwelling adults with dementia (NutriAlz Trial). J Nutr Health Aging. 2013 Apr;17(4):295-9. doi: 10.1007/s12603-012-0401-9.

    PubMed 23538648

  • Salva A, Roque M, Rojano X, Inzitari M, Andrieu S, Schiffrin EJ, Guigoz Y, Vellas B. Falls and risk factors for falls in community-dwelling adults with dementia (NutriAlz trial). Alzheimer Dis Assoc Disord. 2012 Jan-Mar;26(1):74-80. doi: 10.1097/WAD.0b013e318215ca90.

    PubMed 22354139

  • Salva A, Andrieu S, Fernandez E, Schiffrin EJ, Moulin J, Decarli B, Rojano-i-Luque X, Guigoz Y, Vellas B; NutriAlz group. Health and nutrition promotion program for patients with dementia (NutriAlz): cluster randomized trial. J Nutr Health Aging. 2011 Dec;15(10):822-30. doi: 10.1007/s12603-011-0363-3.

    PubMed 22159768

Questions about this trial

What is this clinical trial studying?

A study testing Nutritional programme in people with Alzheimer's Disease and Dementia, run by Société des Produits Nestlé (SPN) at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the effectiveness of the intervention -The main evaluation criteria which will allow the effectiveness of this intervention to be evaluated are the reduction in the loss of autonomy measured by the DA/IDA scale. (time frame: Baseline, 6 months, 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00479843, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2014.

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