The current study is part of a larger project that aims at identifying genetic profiles that render subject vulnerable to pronounced memory decline at old age. This part of the project will assess cognitive functions in three different age cohorts,…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Geen aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is genetic variation (DNA and RNA), which will be
related to memory variation in the Verbal Learning Test (VLT).
Secondary outcome
In the eldest group, the Mini Mental State Examination will provide a more
global indication on cognitive functioning. For all groups, functioning in
related cognitive domains will be assessed using the Visual Association Test,
Digit Span, Fluency, Letter Digit Substitution, Stroop, Trail Making Test,
Paired Associate Learning, and Pattern Separation.
Background summary
Memory impairment is more pronounced in people with a particular genetic
make-up. Whereas some studies have been dedicated to find markers for
pathological states such as AD, findings about 'normal' parameters in healthy
volunteers are rather limited. Studies in younger age groups are scarce, and as
such, little is known about the genetic or, in particular, genomic profile. The
data of the youngest group, which will be collected during this study, will
show the spectrum of genomic variation when cognitive performance is optimal.
Study objective
The current study is part of a larger project that aims at identifying genetic
profiles that render subject vulnerable to pronounced memory decline at old
age. This part of the project will assess cognitive functions in three
different age cohorts, with normal memory performance, on three time points
(once per year). Blood samples will be drawn at each time point to link the
genetic profile with cognitive performance.
Study design
The study is conducted according to a repeated measures design (2 year
follow-up) in three age cohorts (18-30, 40-60, 60-80 years old). Subjects will
be asked to visit the laboratory once a year during which a standardised
cognitive battery will be applied. The genomics (RNA) and genetics (DNA)
parameters obtained from the blood samples at every visit will be linked to
cognitive performance.
Study burden and risks
This study involves minimal risks for the subjects. Time investment will be
around 5 hours in total. It is possible subjects will feel somewhat tired due
to the test procedures and blood sampling can be perceived as painful and can
result in bruises.
One Takeda Parkway 00
Deerfield IL 60015
US
One Takeda Parkway 00
Deerfield IL 60015
US
Listed location countries
Age
Inclusion criteria
1. The subject has to sign and date a written informed consent form prior to the initiation of study procedures;
2. The subject falls in the age-range of one the cohorts, i.e. 18-30; 40-60; 60-80;
3. The subject has good comprehension of the Dutch language
4. Normal memory performance
5. The subject agrees with the fact that he or she will be informed about irregular findings with regard to their medical condition.
Exclusion criteria
- Suffering from uncontrolled, clinically significant neurologic disease or other abnormality which may impact the
ability of the subject to participate or potentially confound the study results, which includes pregnancy and having
received chemo treatment during the past year.
- The presence of psychiatric illness including schizophrenia, depression, bipolar disorder, Attention Deficit
Hyperactivity Disorder and autism;
- Smoking more than 10 cigarettes a day.
- Excessive drinking, i.e. >20 glasses of alcohol containing beverages a week,
- Current use of psychoactive medication (e.g. antidepressants, antipsychotics), centrally acting beta blockers, use of recreational drugs from 2 weeks before until the end of the yearly testing ,
- Any sensory or motor deficits which could reasonably be expected to affect test performance.
- Consultation of a clinical expert for memory problems before having entered the study
- Having received any investigational compound within 60 days prior to the Baseline
(Screening) Visit
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 | NL60887.068.17 |