Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05815329 |
| Other study ID # |
2666 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 2, 2022 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Istituti Clinici Scientifici Maugeri SpA |
| Contact |
Cira Fundarò, Neurologist |
| Phone |
0385247268 |
| Email |
cira.fundaro[@]icsmaugeri.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Subjective cognitive decline-SCD is a subclinical cognitive impairment subjectively
experienced without being detectable from a diagnostic and neuropsychological perspective. It
can negatively impact on patient's frailty and quality of life and it may be prodromal to
severe cognitive impairment. Currently, only a few screening tools focusing mainly on memory
complaints exist.
The aim of this study is to analyze if a new screening tool called MASCoD (Multidimensional
Assessment of Subjective Cognitive Decline) can detect and monitor the SCD, predicting the
risk of developing severe cognitive decline over time.
Specifically, the investigators have the following aims:
primary objectives:
1. To assess the construct validity and tune the clinical cutoffs of the new instrument
through the correlation of MASCoD scores with neuropsychological evaluation and brain
18F-FDG-PET.
2. To assess the clinical validity (predictive capability) of the new instrument through a
classification model (dependent variable: brain 18F-FDG-PET examination; independent
variable: MASCoD; control variables: gender, age and neuropsychological evaluation).
Secondary objective:
To evaluate the suitability of MASCoD as tool for the monitoring of patients over time.
Specifically, the investigators want to evaluate if the MASCoD score is able to assess the
effects of a cognitive treatment and, in turn, to identify outpatients who most likely will
benefit from it.
After the multidimensional evaluation at T0, the participants will be randomly allocated into
an experimental group and a wait list control group. Specifically, cognitive training will be
offered by means of technological devices (Neurotablet).
At T1, all outpatients (experimental group and wait list control group) will be evaluated
through MASCoD and the extensive neuropsychological evaluation for the second time.
Description:
Subjective cognitive decline (SCD) is a subclinical cognitive impairment, which is complained
by the individual without being objectively supported at diagnostic and neuropsychological
levels. It can negatively influence outpatient's frailty and quality of life, as well as
caregiver's burden. It may be associated with anxious and/or depressive symptoms too.
Moreover, it can be prodromal to Mild Cognitive Impairment or dementia. Concerning this
issue, to date, imaging biomarkers (e.g. positron emission tomography - brain 18F-FDG-PET),
can be considered a promising method to predict the development of different forms of future
cognitive decline. However, this examination is very expensive for the healthcare system.
Although the clinical manifestations of SCD can differ along several cognitive domains (e.g.
memory problems, mental slowness and concentration difficulties, self-perceived deterioration
in usual cognitive performance), as far as the investigators know, there are currently only
screening tools to investigate subjective memory complaints.
Rehabilitation can play a pivotal role in this condition and non-pharmacological
interventions on SCD, as cognitive training, could maintain on existing cognitive resources
and slow the rate of possible increasing cognitive decline. To date, lower-functioning
individuals seem to benefit more from cognitive training, in particular concerning working
memory and executive functions (i.e. inhibition).
Thus, a screening tool assessing all possible subclinical manifestations of SCD and risk
factors is needed to support professionals in making differential diagnosis and to predict
the risk of developing severe cognitive impairment over time, proposing a personalized care
path. From a clinical and research standpoint, a useful screening tool is expected to be
brief for usual clinical assessment and research protocol, as well as administrable by
different professionals and in various healthcare settings. Moreover, it should suggest
targeted interventions to maximize the psychophysical outcome. The development of such a
screening tool would address the current shortage of rapid, economic and validated
instruments globally assessing over time cognition affected by this condition.
In light of the above issues, the investigators propose a brief, not expensive,
multidimensional screening tool called MASCoD (Multidimensional Assessment of Subjective
Cognitive Decline) developed on the basis of literature and the clinical experience provided
by an experts' panelist (i.e. psychologists, neuropsychologists, neurologists) employed at
the Institute for Research, Hospitalization and Healthcare (IRCCS) - Istituti Clinici
Scientifici (ICS) Maugeri - Institute of Montescano and Pavia, Italy. It is composed of a
general form for socio-demographic data and the following sections: a) risk factors for SCD;
b) memory and executive symptoms; c) anxious/depressive or distressing symptoms. There are
four increasing risk levels (i.e. low, medium with emotional complaints, medium without
emotional complaints, high risk) of developing a severe cognitive impairment. Two versions of
MASCoD have been proposed: one for the first baseline screening and one for the follow up
assessments.
The aim of this study is to analyze if MASCoD can detect and monitor the SCD, predicting the
risk of developing severe cognitive decline over time.
Specifically, the investigators have the following aims:
primary objectives:
1. To assess the construct validity and tune the clinical cutoffs of the new instrument
through the correlation of MASCoD scores with neuropsychological evaluation and brain
18F-FDG-PET.
2. To assess the clinical validity (predictive capability) of the new instrument through a
classification model (dependent variable: brain 18F-FDG-PET examination; independent
variable: MASCoD; control variables: gender, age and neuropsychological evaluation).
Secondary objective:
To evaluate the suitability of MASCoD as tool for the monitoring of patients over time.
Specifically, the investigators want to evaluate if the MASCoD score is able to assess the
effects of a cognitive treatment and, in turn, to identify outpatients who most likely will
benefit from it.
Eligible patients will be selected among consecutive outpatients requiring a neurological
assessment for possible SCD at: a) ICS) Maugeri - Institute of Montescano,
Neurophysiopatology Unit (DTCP - Diagnostic-Therapeutic Care Pathway for dementia), b)
Neurology Unit Neurology Unit, Civil General Hospital in Voghera (PV) ASST Pavia, c)
Rehabilitation Department Voghera Stradella Mortara (PV) Hospital ASST di Pavia.
The inclusion criteria are the following: reported SCD without any other cognitive or
neurological issue, Italian education, adult (> 55 years old), understanding of research
aims, signed informed consent, participation on a voluntary and non-retributed bases.
The exclusion criteria are the following: serious clinical conditions (e.g. severe cardiac
and respiratory problems, neoplasia) and prior diagnosis of psychiatric disorders according
to DSM-5, prior diagnosis of cognitive decline, relevant visuo-perceptive or hearing
deficits, illiteracy or relapse in illiteracy, refusal to partake into the research.
Form a methodological point of view, outpatients will undergo an extensive neuropsychological
evaluation, brain 18F-FDG-PET, as required by the Maugeri DTCP for cognitive disorders.
After the multidimensional evaluation at T0, the participants will be randomly allocated into
an experimental group and a wait list control group. Specifically, cognitive training will be
offered to half of the outpatients included in this research, by means of technological
devices (Neurotablet). A neuropsychologist will supervise the cognitive training offline
(about 30 minutes per 5 days) and through a face-to-face 1 hour-session each week per each
outpatient. The wait list control group will only perform neuropsychological assessment at
the 6-month follow-up, without any treatment between T0 and T2. The latter will then be able
to perform the same cognitive stimulation training subsequent to the control group and
follow-up evaluation.
At T1, all outpatients (experimental group and wait list control group) will be evaluated
through MASCoD and the extensive neuropsychological evaluation for the second time (6 months-
1 year).
