The primary objectives are to investigate multiple aspects of FDM in patients with AD, MCI and PD compared to healthy controls and to investigate whether FDM problems in these patients can be related to specific neurocognitive dysfunctions. The…
ID
Source
Brief title
Condition
- Mental impairment disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary parameters of this study are the performances of patients with AD,
MCI and PD on FDM tasks compared to healthy controls.
Secondary outcome
The secondary parameters of this study are the performances of patients with
AD, MCI and PD on standard neuropsychological tasks.
Background summary
Financial decision-making (FDM) is a daily-performed activity that is highly
relevant for independent living. FDM requires the integrity of various
cognitive functions and it is likely that FDM is vulnerable to the changes in
cognition and emotion that accompany neurodegenerative disorders. However, the
assessment of FDM is difficult since (1) there is a lack of guidelines and of
standardized and valid instruments and (2) the tests that are available often
only assess one (basic) aspect of FDM. The aim of the present study is to
assess FDM in patients with neurodegenerative disorders, namely Alzheimer*s
disease (AD), Mild cognitive impairment (MCI) and Parkinson*s disease (PD),
using a newly developed test battery, which is sensitive to the effects of
aging and has a good divergent validity.
Study objective
The primary objectives are to investigate multiple aspects of FDM in patients
with AD, MCI and PD compared to healthy controls and to investigate whether FDM
problems in these patients can be related to specific neurocognitive
dysfunctions. The secondary objective is to distinguish specific profiles of
FDM in patients with AD, MCI and PD in terms of strengths and weaknesses.
Study design
Cross-sectional pilot study.
Study burden and risks
Participants will be invited to visit the University Medical Center Groningen
or the Hospital Network Antwerp once for a neuropsychological assessment. Three
weeks before the assessment the participants will receive several
questionnaires (administration time of approximately 0.5 hours) which can be
filled out at home. The assessment in the University Medical Center Groningen
or the Hospital Network Antwerp has a duration of approximately 3,5 to 4 hours.
The assessment will require a certain amount of concentration from which a
participant can recover after a short break. The risks of this study are thus
negligible and the burden can be considered minimal.
Grote Kruisstraat 2/1
Groningen 9712 TS
NL
Grote Kruisstraat 2/1
Groningen 9712 TS
NL
Listed location countries
Age
Inclusion criteria
Patients must be diagnosed with Alzheimer's Disease (AD), Mild Cognitive
Impairment (MCI) or Parkinson's disease (PD) by an experienced neurologist
according to published criteria:
1. Patients with probable AD dementia according to the criteria of The National
Institute on Aging and the Alzheimer*s Association (McKhann et al., 2011).
1a. Only patients in the early stages of the disease (i.e. within two years
after diagnosis) will be included, since in the later stages of disease the
understanding of test instructions might be questioned.
2. Patients with amnestic MCI (single and multi-domain) according to the
criteria of The National Institute on Aging and the Alzheimer*s Association
(Albert et al., 2011).
3. Patients with idiopathic PD according to the UK Parkinson*s Disease Society
Brain Bank Criteria (Hughes, Daniel, Kilford, & Lees, 1992).
3a. Only patients in the early stages of the disease (i.e. within five years
after diagnosis) will be included, since in the later stages of disease the
understanding of test instructions might be questioned., In case of medication
use, patients and healthy controls must be on a stable dosage of medication for
at least one month.
Exclusion criteria
1. Presence of a neurological central nervous system disorders other than AD,
MCI or PD.
2. Surgical treatment for idiopathic PD, such as deep brain stimulation.
3. Other significant co-morbidity which might have an influence on cognition:
3a. Cardiovascular diseases, including severe hypertension.
3b. Cardiovascular risk factors, such as diabetes.
3c. Clinically evident psychological / psychiatric disorders, such as
depression, anxiety, apathy and fatigue.
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 | NL54161.042.15 |