To identify modifiable dietary risk factors for AD,by comparing three patientpopulations in nutritional intake, energy needs, body composition, physical activity and functioning of smell and taste.
ID
Source
Brief title
Condition
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Nutritional intake in patients with AD, in comparison with subjects with
subjective cognitive decline or MCI.
Secondary outcome
Determining changed energy needs and body composition in patients with
(pre-dementia) AD compared to healthy people and patients with advanced AD.
Identifing altered eating behaviour in terms of olfactory and gustatory
functioning, food preferences and satiety as determinants of altered food
intake in patients with (pre-dementia) AD compared to healthy people and
patients with advanced AD.
Establishing relationships between nutritional intake and energy needs & body
composition, and nutritional biomarkers.
Pospectively validating panel of nutritional markers and relate them to
measures of nutritional intake, energy requirements and body composition.
Relating these markers to in*vivo measures of AD pathology (i.e. MRI, CSF
biomarkers for AD, APOE status, EEG).
Background summary
AD has been coined one of the grand challenges of the current century. In 2015,
over 46.8 million people worldwide (260,000 in the Netherlands) suffered from
dementia, with annual costs estimated at US$ 818 billion. The WHO predicts the
number of people with dementia to triple to 131.5 million by 2050.The G8 have
recently made dementia a top priority, as currently, no cure for AD exists.
AD develops gradually over many years. The first brain changes (i.e. amyloid
deposition) can be detected up to 20 years prior to onset of the clinical
syndrome of dementia. As the disease progresses, tau pathology develops and
neuronal injury occurs, eventually leading to memory impairment, global
cognitive decline, and dementia. The predementia clinical stages of subjective
cognitive decline and MCI offer a unique window for preventive intervention.
The promise of preventive strategies has recently been illustrated by the
finding that incidence numbers seem to rise less rapidly than anticipated,
probably due to improved treatment of vascular risk factors, and a growing body
of evidence suggest that nutritional status is a major, often unrecognized
determinant for cognitive decline and AD. So far it remains unclear whether
cognitive decline alters behavioural aspects of food intake, or whether AD
pathology results in altered energy needs and body composition that result in
altered nutritional status, or both.
Study objective
To identify modifiable dietary risk factors for AD,by comparing three
patientpopulations in nutritional intake, energy needs, body composition,
physical activity and functioning of smell and taste.
Study design
NUDAD-L is a prospective cohort study, representing a sub-cohort of NUDAD-XL.
We will include patients who have visited our diagnostic screening. The
duration of follow-up will be three years.
Study burden and risks
Before inclusion, all patients have been screened at the VUmc Alzheimer center,
including comprehensive neuropsychological testing, MRI, EEG, and collection of
blood, DNA and CSF for research purposes. When patients participate in NUDAD-L,
they will undergo additional blood sampling, taste and smell testing, fill out
several questionnaires on food preferences, food intake, physical activity,
appetite, hunger and satiety, and they will have their energy expenditure
measured by indirect calorimetry. At two years follow-up, we will repeat
Fasting blood sampling, the olfactory and gustatory function tests and the 3
day food diary which will be filled out in advance at home. At the visit
patients will receive material to sample their feces at home. This sample can
be send to us. These measurements will take about 1 hour and will be scheduled
on the same day as their regular second clinical follow-up appointment. In
addition, patients will be invited for three annual follow-up visits (visit
medical doctor and neuropsychologist). The risks associated with participation
are negligible and follow-up is organized in much the same way as our routine
clinical follow-up.
De Boelelaan 1118
Amsterdam 1081 HZ
NL
De Boelelaan 1118
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
Label of either subjective cognitive decline, Mild Cognitive Impairment or Alzheimer's Disease Signed informed consent projects P2005_160, P2000_211 (SCD: also SCIENCe P2014-019)
Age * 50 years
MMSE*19
Exclusion criteria
Individuals who are considered medically unstable (assessed by physician)
Insufficient knowledge of Dutch language
Major psychiatric disorder, such as psychosis, schizophrenia, severe personality disorder or depression with vital signs, abuse of alcohol or other substances
Neurological disorder such as Parkinson*s disease, symptomatic stroke, mental retardation
Having a history of other neurological disorders known to influence smell and/or taste
Acquired Immune Deficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV)
Having a severe food allergy
Having a severe disease of the digestive tract, such as celiac disease, Crohn*s disease, active ulcerative colitis, short bowel syndrome
Having a severe metabolic disorder, such as phenyl ketonuria
A recent diagnosis of cancer or being actively treated for cancer (excluding basal cell carcinoma of the skin)
Having a current upper respiratory infection or severe COPD (known GOLD 3 or 4)
Being a regular smoker
In MCI and AD patients: unavailability of a study partner to assist with the participation of NUDAD-L in patients with dementia
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL55116.029.15 |