The overall aim of this study is to develop a short and clinically relevant composite measure, which is able to detect changes in cognition and everyday functioning across the disease spectrum of Alzheimer*s Disease (AD). We will achieve this aim by…
ID
Source
Brief title
Condition
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is clinical progression in cognition and everyday
functioning, as measured with the CFC. Reference measures for this progression
consist of cognitive screening tests, caregiver-based anchor measurements of
change and Magnetic Resonance Imaging (MRI). Progression of disease burden will
be assessed using caregiver burden, quality of life and level of apathy
measures and social functioning. For the validation of the CFC, we will relate
changes on the CFC to these other measures of disease progression.
Secondary outcome
Secondary parameters are age, gender, education, culture and disease severity
at baseline. We will investigate their possible influence on the CFC.
Background summary
Neuropsychological testing is burdensome to patients with dementia. However, it
is essential for the monitoring of disease progression and the evaluation of
treatment effects. Neuropsychological assessment should therefore be short,
reliable, valid, sensitive to change and reflect clinically meaningful changes.
Commonly used neuropsychological tests do not meet these criteria. There is
therefore a need to specify and validate measures suitable for assessing
disease progression in dementia.
Study objective
The overall aim of this study is to develop a short and clinically relevant
composite measure, which is able to detect changes in cognition and everyday
functioning across the disease spectrum of Alzheimer*s Disease (AD). We will
achieve this aim by addressing the following key objectives: First (1), we will
identify the relevant cognitive and everyday functioning measures and create
the Cognitive-Functional Composite (CFC). Next (2), we aim to investigate the
psychometric properties of the CFC and investigate whether it is able to detect
changes over time. Lastly (3), we aim to investigate possible influence of age,
gender, educational and cultural differences on the CFC.
Study design
This multicenter study has a mixed methods design. First, we will use both
qualitative and quantitative methods to develop the CFC. Following this, we
will perform a longitudinal validation study consisting of a prognostic cohort
with baseline 3-, 6-, and 12-month follow-up assessments.
Study burden and risks
Patients participating in our study will undergo a neuropsychological
assessment and clinical evaluation at four measurement moments: namely
baseline, 3, 6 and 12 months. Each measurement moment has an assessment time of
approximately 90 minutes for the patient and 45 minutes for the caregiver. The
time intervals between measurement moments are chosen to correspond to clinical
and intervention trials. We realize that the frequency of these moments could
provide a high burden. To minimize respondent burden, we will offer testing at
home. Questionnaires for caregivers can be completed at home as well. Patients
only need to visit their memory clinic for the MRI scan at baseline and 12
months follow-up. However we aspire to inlude a diagnostic scan as baseline
scan if available. In that case, only a follow-up scan at 12 months will be
acquired. The conduction of the MRI scan might be uncomfortable and is
therefore not obligatory for participation in the study. The additional risk of
this study is considered negligible, as no experimental intervention is
conducted. The current study will not benefit patients and caregivers directly.
However if successful, the CFC will contribute to the improvement of
longitudinal measurements in early stages of dementia.
De Boelelaan 1118
Amsterdam 1081 HV
NL
De Boelelaan 1118
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Patients: 1) A diagnosis of subjective cognitive decline, mild cognitive impairment (MCI) or dementia due to Alzheimer's Disease (AD) OR MCI or mild dementia due to Dementia with Lewy bodies (DLB); 2) MMSE >= 18; 3) Age >= 50; 4) Written informed consent; 5) Availability of a primary caregiver;Control group: age >= 50, cognitively normal
Exclusion criteria
Presence of a neurological disease other than AD or DLB; Presence of another major psychiatric disorder (according to Diagnostic and Statistical Manual of Mental Disorders, 4th version); Current abuse of alcohol or drugs; Currently participating in a clinical trial.
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 | NL53667.029.15 |