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Trial of a Nutritional Blend to Prevent Cognitive Decline in Older Adults

Primary Purpose

Cognitive Decline

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Nutrional blend of ingredients including vitamins and fish oil
Control
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cognitive Decline focused on measuring Aging population

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥ 70 years
  2. Spontaneous memory complaints
  3. Adequate fluency in the local language to understand the inform consent form and complete any other study document
  4. Sufficient vision and hearing to complete study protocol procedures based on medical judgement
  5. Has a study partner that is willing to participate as a source of information and has at least weekly contact with the participant (contact can be in-person, via telephone or electronic communication)
  6. Has general health status that will not interfere with the ability to complete the study
  7. Willing and able to participate and to give written consent to comply with study procedures
  8. Willing to be informed in case a new clinical pathology is discovered through clinical examinations

Exclusion Criteria:

  1. Exhibiting a loss of independence in basic activities of daily living (ADL score < 4)
  2. MMSE score < 24
  3. Dementia as determined by DSM-V criteria
  4. Suffering from diseases that are likely to be life-threatening in the short-term
  5. History or presence of a severe disease (e.g., cardiovascular, hepatic, renal (e.g., End Stage Renal Disease), gastroenteral, respiratory, endocrine, neurologic, psychiatric, immunologic, or hematologic disease or other conditions) that could, in the opinion of the investigator, interfere with the subjects safety or ability to complete the trial
  6. Food allergy
  7. Taking omega-3 dietary supplements containing >200 mg DHA per day during the last 6 months
  8. Receiving or having received in the past 3 months a physician prescribed vitamin B12, B3 or vitamin B-complex
  9. Receiving Alzheimer's Disease medication (Galantamine, Memantine Donezepil and Rivastigmine)
  10. Deprived of their liberty by administrative or judicial decision, or under guardianship or admitted to a healthcare or social institution (subjects in non-assisted living facilities could be recruited).
  11. Having participated in another clinical study in the previous month or is currently participating in another study.

    Subjects meeting one or more of the following criteria below will not be included in the PET scan and MRI-scan subset groups:

  12. Wearing a pace-maker or having metal in the body which is exclusionary for MRI
  13. Claustrophobic

Subjects who will participate in the PET-scan and MRI-scan subset groups, will be excluded for a 1-year period of any future projects involving investigations using ionizing radiation.

Sites / Locations

  • CHU Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental

Control comparator:

Arm Description

Nutritional blend of ingrédients including vitamins and fish oil

control product does not contain any of the active ingredients and is matched for carbohydrate content to the active intervention.

Outcomes

Primary Outcome Measures

Changes at 1 year in levels of nutritional risk factors involved in cognitive decline with ageing relative to baseline
Plasma erythrocyte-omega 3 index
Changes at 1 year in levels of nutritional risk factors involved in cognitive in cognitive decline with ageing relative to baseline
Homocysteine levels

Secondary Outcome Measures

Change in cognitive function determined by a composite Z-score from 4 neuropsychological tests (see description) at 0, 6 and 12 months
The composite score combines the scores of the following neuropsychological tests: FCSRT score as the sum of free recall (sum of the three learning tests) and of cued recall (sum of free recall and indexed recall), Orientation score (10 items) from MMSE, Number of symbols reported during 90 sec (Digit symbol Substitution test) and the Number of words reported during 2-minutes (Category naming test)
Changes in cognitive function assessed by the FCSRT (Free and Cued Selective Reminding Test) at 0, 6 and 12 months
FCSRT score as the sum of free recall (sum of the three learning tests) and of cued recall (sum of free recall and indexed recall)
Changes in cognitive function assessed by the Orientation score from the Mini Mental Scale Examination (MMSE) at 0, 6 and 12 months
Orientation score: Subcale of MMSE (see outcome 8); score from 0 to 10.
Changes in cognitive function assessed by the WAIS-IV coding test at 0, 6 and 12 months
Number of symbols reported during 90 seconds
Changes in cognitive function assessed by the Category Naming Test (CNT) at 0, 6 and 12 months
Number of words reported during 2 minutes
Cognitive function assessed by the (Mini Mental Scale Examination) MMSE total score at 6 and 12 months
Total score of the MMSE from 0 to 30. Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.
Cognitive status changes assessed by the Trail Making Test parts A and B at 0, 6 and 12 months
Time in sec to complete Trail Making Test parts A and B
Cognitive status changes assessed by the Logical Memory subtest of the WMS-R Test at 0, 6 and 12 months
Number of correct story elements recalled
Cognitive status changes assessed by the Letter Fluency Test at 0, 6 and 12 months
Number of correct words reported in 2 minutes
Cognitive status changes assessed by the Stroop Color Word Test (SCWT) at 0, 6 and 12 months
Time required to complete each sub-test and interference measure
Cognitive status changes assessed by the Digit Span (DS) at 0, 6 and 12 months
Number of digits recalled for forwards and backward sequences
Change in cognitive impairment assessed by the Clinical Dementia Rating - Sum of Boxes (CDR-SOB) at 0 and 12 months
CDR-SOB score ranging from 0 to 18 (0: Normal ; 0.5-4: Questionable cognitive impairment ; 4.5-9: Mild dementia ; 9.5-15.5: Moderate dementia ; 16-18: Severe dementia)
Change in clinical status assessed by Clinical Dementia Rating (CDR) at 0 and 12 months
Conversion rates to Mild cognitive impairment (MCI) and to dementia (0 = Normal, 0.5= very mild dementia, 1= mild dementia, 2 = moderate dementia, 3= severe dementia)
Subjective change in cognitive function assessed by the PROMIS Applied Cognition - Abilities instrument, Cognitive Function Instrument at 0, 1 and 12 months
PROMIS score: 33 items noted from 0 to 5 (Min score= 0, Max score =165) not used as diagnosis score but to assess the performance from baseline
Subjective change in quality of life and health status assessed by the EQ-5D-5L questionnaire at 0 and 12 months
EQ-5D-5L score: EQ-5D-5L, 5 item questionnaire and a visual analogue scale ranging from 0-100 to describe health status
Changes in depression status assessed by the Geriatric depression scale (GDS) at 0 and 12 months
GDS score ranging from 0 to 15: 0-9: Normal ; 10-19: Mild depression ; 20-30 : Severe depression.
Changes in depression, anxiety and psychiatric symptoms assessed by the Neuropsychiatric Inventory Questionnaire (NPI-Q) at 0 and 12 months
Change in the presence (yes-no) and severity score (1: mild; 2: moderate; 3: severe) of 12 neuropsychiatric symptoms related to dementia, as well as informant distress score for each of the present symptoms (from 0: 'No distress' to 5: 'Extreme distress') measured at 0 and 12 months.
Changes in physical functions assessed by the Short Physical Performance Battery (SPPB) at 0, 6 and 12 months
SPPB score ranging from 0 to 12. Assessment of score's evolution from baseline to 12 months.
Changes in frailty syndromes assessed by the Fried Frailty Criteria at 0 and 12 months
Grip strength, timed walking, involuntary weight loss, fatigue and physical activity (categories: robust, pre-frail, frail)
Changes in brain structure assessed by Magnetic Resonance Imaging (MRI) in a subset of the study population at 0 and 12 months
Regional tissue volume, Regional tissue thickness, Regional surface area, Intracranial volume (total, regional), Total brain volume, Regional volume (eg hippocampus)
Changes in brain structure assessed by fluid-attenuated inversion recovery (FLAIR) MRI and diffusion tensor imaging (DTI) in a subset of the study population at 0 and 12 months
Total white matter lesion volume
Changes in brain function assessed by Arterial spin label (ASL) perfusion MRI in a subset of the study population at 0 and 12 months
Cerebral blood flow
Changes in brain function assessed by resting State fMRI in a subset of the study population at 0 and 12 months
Brain connectivity
Changes in brain structure assessed by MRI diffusion tensor imaging (DTI) in a subset of the study population at 0 and 12 months
White matter integrity
Changes in brain function assessed by Amyloid Florbetapir Positron Emission Tomography (PET) in a subset of the study population at baseline
Amyloid load
Changes in levels of biomarkers associated with cognitive decline: BDNF levels at 0, 6 and 12 months
Brain-Derived Neurotrophic Factor (BDNF) plasma levels
Changes in levels of biomarkers associated with cognitive decline: Aβ40 levels at 0, 6 and 12 months
Aβ40 plasma levels
Changes in levels of biomarkers associated with cognitive decline: Aβ42 levels at 0, 6 and 12 months
Aβ42 plasma levels
Changes in levels of biomarkers associated with cognitive decline: Tau protein levels at 0, 6 and 12 months
Tau protein plasma levels
Changes in levels of biomarkers associated with cognitive decline: Asymmetric dimethylarginine levels at 0, 6 and 12 months
Asymmetric dimethylarginine plasma levels
Changes in levels of biomarkers associated with cognitive decline: Homocysteine levels at 0, 6 and 12 months
Homocysteine plasma levels
Changes in levels of blood plasma inflammatory markers 0, 6 and 12 months
Inflammatory markers (sCAMs, E-Selectin, TNF-alpha, IL1, IL6, IL10, CRP, neopterin)
Changes in levels of blood plasma markers of oxidative stress at 0, 6 and 12 months
Markers of oxidative stress (Oxidized Low-density lipoprotein (oxLDL), F2-isoprostane)
Changes in levels of plasma nutrient levels at 0, 6 and 12 months
e.g.vitamins, minerals, lipids, amino acids, erythrocyte omega-3 index
Treatment effects in a subgroup population defined by the below described subject characteristic:
Clinical Dementia Rating (CDR) of 0.5 at baseline
Treatment effects in a subgroup population defined by the below described subject characteristic:
Low DHA status (erythrocyte omega 3 index in the lower quartile) at baseline
Treatment effects in a subgroup population defined by the below described subject characteristic:
High plasma homocysteine levels (plasma homocysteine ≥ 12 µmol/L) at baseline
Treatment effects in a subgroup population defined by the below described subject characteristic:
CAIDE (Cardiovascular Risk Factors, Aging and Dementia) risk score at baseline
Treatment effects in a subgroup population defined by the below described subject characteristic:
Genotype

Full Information

First Posted
October 18, 2016
Last Updated
May 22, 2019
Sponsor
Société des Produits Nestlé (SPN)
Collaborators
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT03080675
Brief Title
Trial of a Nutritional Blend to Prevent Cognitive Decline in Older Adults
Official Title
Trial of a Nutritional Blend to Prevent Cognitive Decline in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
February 26, 2019 (Actual)
Study Completion Date
February 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)
Collaborators
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To demonstrate the beneficial effects of 1-year intervention with a nutritional blend of ingredients on blood levels of nutritional biomarkers known to be linked with cognitive decline in non-demented adults with subjective memory concerns aged 70+ years
Detailed Description
This multicenter trial will be a placebo-controlled, double-blind, randomized, 2 parallel groups study. The subjects will be randomly allocated to one of two treatment groups (placebo or nutrition product). The duration of the intervention is 1 year. The total sample size at baseline is 364 subjects, consisting of non-demented adults with subjective memory concerns aged 70+ years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline
Keywords
Aging population

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
362 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Nutritional blend of ingrédients including vitamins and fish oil
Arm Title
Control comparator:
Arm Type
Placebo Comparator
Arm Description
control product does not contain any of the active ingredients and is matched for carbohydrate content to the active intervention.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutrional blend of ingredients including vitamins and fish oil
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Primary Outcome Measure Information:
Title
Changes at 1 year in levels of nutritional risk factors involved in cognitive decline with ageing relative to baseline
Description
Plasma erythrocyte-omega 3 index
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Changes at 1 year in levels of nutritional risk factors involved in cognitive in cognitive decline with ageing relative to baseline
Description
Homocysteine levels
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Secondary Outcome Measure Information:
Title
Change in cognitive function determined by a composite Z-score from 4 neuropsychological tests (see description) at 0, 6 and 12 months
Description
The composite score combines the scores of the following neuropsychological tests: FCSRT score as the sum of free recall (sum of the three learning tests) and of cued recall (sum of free recall and indexed recall), Orientation score (10 items) from MMSE, Number of symbols reported during 90 sec (Digit symbol Substitution test) and the Number of words reported during 2-minutes (Category naming test)
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Changes in cognitive function assessed by the FCSRT (Free and Cued Selective Reminding Test) at 0, 6 and 12 months
Description
FCSRT score as the sum of free recall (sum of the three learning tests) and of cued recall (sum of free recall and indexed recall)
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Changes in cognitive function assessed by the Orientation score from the Mini Mental Scale Examination (MMSE) at 0, 6 and 12 months
Description
Orientation score: Subcale of MMSE (see outcome 8); score from 0 to 10.
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Changes in cognitive function assessed by the WAIS-IV coding test at 0, 6 and 12 months
Description
Number of symbols reported during 90 seconds
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Changes in cognitive function assessed by the Category Naming Test (CNT) at 0, 6 and 12 months
Description
Number of words reported during 2 minutes
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Cognitive function assessed by the (Mini Mental Scale Examination) MMSE total score at 6 and 12 months
Description
Total score of the MMSE from 0 to 30. Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Cognitive status changes assessed by the Trail Making Test parts A and B at 0, 6 and 12 months
Description
Time in sec to complete Trail Making Test parts A and B
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Cognitive status changes assessed by the Logical Memory subtest of the WMS-R Test at 0, 6 and 12 months
Description
Number of correct story elements recalled
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Cognitive status changes assessed by the Letter Fluency Test at 0, 6 and 12 months
Description
Number of correct words reported in 2 minutes
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Cognitive status changes assessed by the Stroop Color Word Test (SCWT) at 0, 6 and 12 months
Description
Time required to complete each sub-test and interference measure
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Cognitive status changes assessed by the Digit Span (DS) at 0, 6 and 12 months
Description
Number of digits recalled for forwards and backward sequences
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Change in cognitive impairment assessed by the Clinical Dementia Rating - Sum of Boxes (CDR-SOB) at 0 and 12 months
Description
CDR-SOB score ranging from 0 to 18 (0: Normal ; 0.5-4: Questionable cognitive impairment ; 4.5-9: Mild dementia ; 9.5-15.5: Moderate dementia ; 16-18: Severe dementia)
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Change in clinical status assessed by Clinical Dementia Rating (CDR) at 0 and 12 months
Description
Conversion rates to Mild cognitive impairment (MCI) and to dementia (0 = Normal, 0.5= very mild dementia, 1= mild dementia, 2 = moderate dementia, 3= severe dementia)
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Subjective change in cognitive function assessed by the PROMIS Applied Cognition - Abilities instrument, Cognitive Function Instrument at 0, 1 and 12 months
Description
PROMIS score: 33 items noted from 0 to 5 (Min score= 0, Max score =165) not used as diagnosis score but to assess the performance from baseline
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Subjective change in quality of life and health status assessed by the EQ-5D-5L questionnaire at 0 and 12 months
Description
EQ-5D-5L score: EQ-5D-5L, 5 item questionnaire and a visual analogue scale ranging from 0-100 to describe health status
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Changes in depression status assessed by the Geriatric depression scale (GDS) at 0 and 12 months
Description
GDS score ranging from 0 to 15: 0-9: Normal ; 10-19: Mild depression ; 20-30 : Severe depression.
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Changes in depression, anxiety and psychiatric symptoms assessed by the Neuropsychiatric Inventory Questionnaire (NPI-Q) at 0 and 12 months
Description
Change in the presence (yes-no) and severity score (1: mild; 2: moderate; 3: severe) of 12 neuropsychiatric symptoms related to dementia, as well as informant distress score for each of the present symptoms (from 0: 'No distress' to 5: 'Extreme distress') measured at 0 and 12 months.
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Changes in physical functions assessed by the Short Physical Performance Battery (SPPB) at 0, 6 and 12 months
Description
SPPB score ranging from 0 to 12. Assessment of score's evolution from baseline to 12 months.
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Changes in frailty syndromes assessed by the Fried Frailty Criteria at 0 and 12 months
Description
Grip strength, timed walking, involuntary weight loss, fatigue and physical activity (categories: robust, pre-frail, frail)
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Changes in brain structure assessed by Magnetic Resonance Imaging (MRI) in a subset of the study population at 0 and 12 months
Description
Regional tissue volume, Regional tissue thickness, Regional surface area, Intracranial volume (total, regional), Total brain volume, Regional volume (eg hippocampus)
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Changes in brain structure assessed by fluid-attenuated inversion recovery (FLAIR) MRI and diffusion tensor imaging (DTI) in a subset of the study population at 0 and 12 months
Description
Total white matter lesion volume
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Changes in brain function assessed by Arterial spin label (ASL) perfusion MRI in a subset of the study population at 0 and 12 months
Description
Cerebral blood flow
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Changes in brain function assessed by resting State fMRI in a subset of the study population at 0 and 12 months
Description
Brain connectivity
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Changes in brain structure assessed by MRI diffusion tensor imaging (DTI) in a subset of the study population at 0 and 12 months
Description
White matter integrity
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Changes in brain function assessed by Amyloid Florbetapir Positron Emission Tomography (PET) in a subset of the study population at baseline
Description
Amyloid load
Time Frame
[Time Frame: 1 years] [Safety Issue: No]
Title
Changes in levels of biomarkers associated with cognitive decline: BDNF levels at 0, 6 and 12 months
Description
Brain-Derived Neurotrophic Factor (BDNF) plasma levels
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Changes in levels of biomarkers associated with cognitive decline: Aβ40 levels at 0, 6 and 12 months
Description
Aβ40 plasma levels
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Changes in levels of biomarkers associated with cognitive decline: Aβ42 levels at 0, 6 and 12 months
Description
Aβ42 plasma levels
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Changes in levels of biomarkers associated with cognitive decline: Tau protein levels at 0, 6 and 12 months
Description
Tau protein plasma levels
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Changes in levels of biomarkers associated with cognitive decline: Asymmetric dimethylarginine levels at 0, 6 and 12 months
Description
Asymmetric dimethylarginine plasma levels
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Changes in levels of biomarkers associated with cognitive decline: Homocysteine levels at 0, 6 and 12 months
Description
Homocysteine plasma levels
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Changes in levels of blood plasma inflammatory markers 0, 6 and 12 months
Description
Inflammatory markers (sCAMs, E-Selectin, TNF-alpha, IL1, IL6, IL10, CRP, neopterin)
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Changes in levels of blood plasma markers of oxidative stress at 0, 6 and 12 months
Description
Markers of oxidative stress (Oxidized Low-density lipoprotein (oxLDL), F2-isoprostane)
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Changes in levels of plasma nutrient levels at 0, 6 and 12 months
Description
e.g.vitamins, minerals, lipids, amino acids, erythrocyte omega-3 index
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Treatment effects in a subgroup population defined by the below described subject characteristic:
Description
Clinical Dementia Rating (CDR) of 0.5 at baseline
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Treatment effects in a subgroup population defined by the below described subject characteristic:
Description
Low DHA status (erythrocyte omega 3 index in the lower quartile) at baseline
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Treatment effects in a subgroup population defined by the below described subject characteristic:
Description
High plasma homocysteine levels (plasma homocysteine ≥ 12 µmol/L) at baseline
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Treatment effects in a subgroup population defined by the below described subject characteristic:
Description
CAIDE (Cardiovascular Risk Factors, Aging and Dementia) risk score at baseline
Time Frame
[Time Frame: 1 year] [Safety Issue: No]
Title
Treatment effects in a subgroup population defined by the below described subject characteristic:
Description
Genotype
Time Frame
[Time Frame: 1 year] [Safety Issue: No]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 70 years Spontaneous memory complaints Adequate fluency in the local language to understand the inform consent form and complete any other study document Sufficient vision and hearing to complete study protocol procedures based on medical judgement Has a study partner that is willing to participate as a source of information and has at least weekly contact with the participant (contact can be in-person, via telephone or electronic communication) Has general health status that will not interfere with the ability to complete the study Willing and able to participate and to give written consent to comply with study procedures Willing to be informed in case a new clinical pathology is discovered through clinical examinations Exclusion Criteria: Exhibiting a loss of independence in basic activities of daily living (ADL score < 4) MMSE score < 24 Dementia as determined by DSM-V criteria Suffering from diseases that are likely to be life-threatening in the short-term History or presence of a severe disease (e.g., cardiovascular, hepatic, renal (e.g., End Stage Renal Disease), gastroenteral, respiratory, endocrine, neurologic, psychiatric, immunologic, or hematologic disease or other conditions) that could, in the opinion of the investigator, interfere with the subjects safety or ability to complete the trial Food allergy Taking omega-3 dietary supplements containing >200 mg DHA per day during the last 6 months Receiving or having received in the past 3 months a physician prescribed vitamin B12, B3 or vitamin B-complex Receiving Alzheimer's Disease medication (Galantamine, Memantine Donezepil and Rivastigmine) Deprived of their liberty by administrative or judicial decision, or under guardianship or admitted to a healthcare or social institution (subjects in non-assisted living facilities could be recruited). Having participated in another clinical study in the previous month or is currently participating in another study. Subjects meeting one or more of the following criteria below will not be included in the PET scan and MRI-scan subset groups: Wearing a pace-maker or having metal in the body which is exclusionary for MRI Claustrophobic Subjects who will participate in the PET-scan and MRI-scan subset groups, will be excluded for a 1-year period of any future projects involving investigations using ionizing radiation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno VELLAS
Organizational Affiliation
CHU Toulouse, Gérontopôle, Cité de la Santé, 20 Rue du Pont Saint Pierre, 31059 TOULOUSE Cedex 9
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Trial of a Nutritional Blend to Prevent Cognitive Decline in Older Adults

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