Condition category
Nervous System Diseases
Date applied
19/06/2018
Date assigned
20/06/2018
Last edited
20/06/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Studies show that nutrients in our food are important for brain health and can also reduce the risk of developing Alzheimer's disease (AD). AD is a disease that impacts memory and language and is associated with emotional and behavioral problems. Omega-3 fatty acids, which are found in high concentrations in fish oil and in fatty fish such salmon and herring, are thought to improve brain function. Other food items (nutrients) of interest include carotenoids, which are powerful antioxidants (substances that prevent harmful oxygen reactions) found in many fruits and vegetables. Studies suggest that vitamin E may provide protection against a loss of brain function. This study aims to test a unique nutritional strategy, combining three carotenoids (lutein, zeaxanthin and meso-zeaxanthin), omega-3 fatty acids and vitamin E to potentially slow the worsening of AD and aid in the management of this disease.

Who can participate?
120 males and females with mild to moderate Alzheimer's disease can participate in the study.

What does the study involve?
80 subjects will swallow 3 capsules a day, containing: 22 mg macular carotenoids, 1 gram fish oil and 15 mg Vitamin E, this is called an active ingredients capsule. 40 subjects will similarly swallow 3 capsules a day but containing sunflower oil, this is known as a placebo capsule. The researchers and the participants will not know who is receiving the active or placebo capsules for the duration of the study, since both capsules are identical in appearance. Participants will take the capsules every day (3 soft gel capsules with a meal) and will be followed for 24 months. Study visits are performed in the participant's home study at baseline, month 12 and month 24 (final visit). At each study visit, the participant and their carer will be interviewed or will fill out questionnaires, the participant will take a vision test, the participant's intake of certain foods will be recorded, the participant's skin concentration of carotenoids will be measured using a test where they hold their hand onto a scanner, and blood samples will be taken.

What are the potential benefits and risks of participating?
We expect no risks to individuals participating in this study. All the nutritional supplements have been studied and are considered safe to consume. We hope that society will benefit from the research. In the absence of a cure for Alzheimer's disease, we hope to potentially slow the progression of Alzheimer's disease.

Where is the study run from?
The Nutrition Research Centre Ireland, Waterford Institute of Technology (Ireland).

When is the study starting and how long is it expected to run for?
May 2018 to May 2021

Who is funding the study?
The Howard Foundation

Who is the main contact?
Stephanie Byrne
stephanie.byrne@postgrad.wit.ie

Trial website

Contact information

Type

Scientific

Primary contact

Prof John Nolan

ORCID ID

Contact details

Carriganore House
Waterford Institute of Technology West Campus
Carriganore
Waterford
X91K236
Ireland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

re-MIND version 1

Study information

Scientific title

Memory Intervention with Nutrition for Dementia (re-MIND): to investigate the impact of dietary nutrient supplements on the natural progression of individuals with Alzheimer's disease

Acronym

re-MIND

Study hypothesis

The aim of the study is to provide dietary nutrient supplements to a group of individuals with mild to moderate Alzheimer's disease (AD) and investigate the supplement's impact on the natural progression of the individuals' AD.

Ethics approval

Waterford Institute of Technology Research Ethics Committee, 17/05/2018, 18/HS-NRCI/01

Study design

Single-centre randomised double-blind placebo-controlled intervention trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Alzheimer's disease

Intervention

Block randomisation will be performed using a trial management system “Trial Controller” designed by our research group. 120 patients will be randomised in a 2:1 (Active:Placebo) masked fashion.
80 AD subjects will consume 3 active capsules a day, combined the soft gels contain: 10 mg L, 10 mg MZ, 2 mg Z, 1 g fish oil and 15 mg alpha-tocopherol.
40 AD subjects will consume 3 placebo capsules (sunflower oil) a day.
Subjects will consume the intervention every day (3 soft gels with a meal) and will be followed for 24 months. Study visits are at baseline, month 12 and month 24 (final visit).

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

AD progression assessed using using mini mental state examination (MMSE) at baseline (visit 1), 12 months (visit 2) and 24 months (final visit). MMSE is a 30-point questionnaire that can be used to systematically and thoroughly assess mental status. It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. Mild to moderate AD is defined as score of 10 to 25.

Secondary outcome measures

1.Quality of life, assessed using using Quality of life in Alzheimer's Disease family and Participant version (QOL-AD). QOL-AD is a 13-item scale (total score range 13–52; higher scores indicate better QOL). The QOL-AD scale uses a scale of 1–4 (poor, fair, good, or excellent) to rate a variety of life domains, including the patient’s physical health, mood, relationships, activities, and ability to complete tasks. The researcher will interview the patient and patient’s carer separately.
2. Functional ability assessed using Dementia Severity Rating Scale (DSRS) and Clinical frailty score.
2.1. The DSRS is an informant-based, multiple-choice questionnaire that assesses severity from the mildest to the most severe stages in the major functional and cognitive domains affected in AD. Sections include: memory, speech and language, recognition of family members, orientation to time, orientation to place, ability to make decisions, social and community activity, home activities and responsibilities, personal care/cleanliness, eating, control of urination and bowels, and ability to get from place to place. Results are interpreted by adding up the points for all sections. Score of 0-18: mild, score of 19-36: moderate, and score of 37-54: severe.
2.2. Clinical frailty score (0-9) is recorded by the research nurse using a visual analogue scale. It is expected that mild to moderate AD patients will have a high score (i.e. 7). Functional ability will be evaluated by assessing the scores of each test over time (i.e. improvements, no changes and/or decline over 24 months).
3. Clinical collateral: a descriptive “story” of each subject will be recorded by the researcher including an interview of the patient’s carer (the primary person responsible for caring for the patient with Alzheimer's disease) to assess the patient’s health status and medical observations. Structured questions include:
3.1. Have you noticed any change in the patient's memory (same, worse, better)?
3.2. What are the main memory concerns?
3.3. How are they managing every activities – specifically getting dressed, making a cup of tea, cooking, grocery shopping?
3.4. Has there been a change in personality – specifically agitation, wandering, low mood, sleep disturbance?
4. Near acuity and contrast sensitivity measured using the M&S Technologies system. The test is carried out in the patient's home and controlled by the researcher using a smart system tablet (Android). The research nurse can customize the layout (e.g. distance and symbols) to each patient’s preference.
5. Dietary intake of lutein (L), zeaxanthin (Z), and omega. L and Z levels in the diet are assessed by inputting the patient’s weekly intake of carotenoid-rich foods (eggs, broccoli, corn, dark leafy vegetables) into the 'L/Z screener' to give a carotenoid-based diet score. Values are weighted for frequency of intake of the food and for bioavailability of L and Z within these foods. A ranking score reflecting the relative intakes (representing arbitrary units) will be generated and used in analysis. Similarly, a subject’s weekly intake of fish (e.g. herring, sardines, salmon) and seeds (linseed oil and flaxseeds) will be inputted into the 'Omega screener' to give a gram per day omega consumption. AD subject’s dietary habits will be confirmed by a family member or carer.
6. Measurement of serum concentrations of L, Z, meso-zeaxanthin (MZ), and vitamin E assessed using non-fasting blood samples.
7. Skin carotenoid concentration scores assessed using the Pharmanex® BioPhotonic S3 Scanner. This scanner measures carotenoid levels in human tissue at the skin surface (palm of the hand) using optical signals (resonant Raman spectroscopy). These signals identify the unique molecular structure of carotenoids, allowing their measurement without interference by other molecular substances. The individual is asked to place a specific point (between the maximal and distal palmar creases, directly below the fifth finger) of their right hand in front of the scanner’s low-energy blue light for 30 seconds. From this, a skin carotenoid score (SCS) will be generated, which provided an indication of the individual’s overall antioxidant levels. This was repeated twice more and an average score was calculated. This technology is safe and has been previously validated against serum carotenoid concentrations.
8. Gas chromatography analysis of DHA and EPA assessed using non-fasting blood samples.

All secondary outcome measures will be measured at baseline (visit 1), 12 months (visit 2) and 24 months (final visit).

Overall trial start date

30/05/2018

Overall trial end date

30/05/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Diagnosis of mild to moderate Alzheimer's disease
2. Aged >65 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Consumption of carotenoids and/or omega supplements within the last 3 months
2. Inability to swallow capsules
3. Depression (under active review and medication change)
4. Previously confirmed stroke disease and/or infarct on brain scan
5. Mini-Mental State Evaluation (MMSE) >24
6. Intact clock drawing test and semantic fluency test (i.e. naming more than 11 objects starting with the letter F in 1 minute)

Recruitment start date

01/08/2018

Recruitment end date

30/01/2019

Locations

Countries of recruitment

Ireland

Trial participating centre

Now-Science Consultancy Limited
Waterford
X91 K236
Ireland

Sponsor information

Organisation

Now-Science Consultancy Limited

Sponsor details

C/O Carriganore House
WIT West Campus
Carriganore
Waterford
x91k236
Ireland

Sponsor type

Industry

Website

Funders

Funder type

Not defined

Funder name

The Howard Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publications in a high-impact peer reviewed journal expected to be published.

IPD sharing statement:
The data sharing plans are currently unknown and will be made available at a later date.

Intention to publish date

30/04/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes