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Original Research Article

Symptoms of Early Dementia-11 Questionnaire

(SED-11Q): A Brief Informant-Operated Screening
for Dementia
Yohko Maki a, b Tomoharu Yamaguchi a, c Haruyasu Yamaguchi a
a Gunma University School of Health Sciences, b Geriatrics Research Institute and Hospital, and
c Department of Rehabilitation, Gunma University of Health and Welfare, Maebashi, Japan

Key Words
Dementia screening · Dementia · Alzheimer’s disease · Activities of daily living · Cognitive
deficits · Early detection · Mild cognitive impairment · Non-Alzheimer’s disease

Abstract
The aim of this study was to develop a brief informant-based questionnaire, namely the Symp-
toms of Early Dementia-11 Questionnaire (SED-11Q), for the screening of early dementia. 459
elderly individuals participated, including 39 with mild cognitive impairment in the Clinical
Dementia Rating scale (CDR) 0.5, 233 with mild dementia in CDR 1, 106 with moderate de-
mentia in CDR 2, and 81 normal controls in CDR 0. Informants were required to fill out a 13-
item questionnaire. Two items were excluded after analyzing sensitivities and specificities. The
final version of the SED-11Q assesses memory, daily functioning, social communication, and
personality changes. Receiver operator characteristic curves assessed the utility to discrimi-
nate between CDR 0 (no dementia) and CDR 1 (mild dementia). The statistically optimal cutoff
value of 2/3, which indicated a sensitivity of 0.84 and a specificity of 0.90, can be applied in
the clinical setting. In the community setting, a cutoff value of 3/4, which indicated a sensitiv-
ity of 0.76 and a specificity of 0.96, is recommended to avoid false positives. The SED-11Q re-
liably differentiated nondemented from demented individuals when completed by an infor-
mant, and thus is practical as a rapid screening tool in general practice, as well as in the
community setting, to decide whether to seek further diagnostic confirmation.
Copyright © 2013 S. Karger AG, Basel

Introduction

There is widespread underascertainment of Alzheimer’s disease (AD) and other

dementias [1], and a combination of pharmacological and nonpharmacological treatments
could slow disease progression and maintain individuals at their highest level of functioning

Haruyasu Yamaguchi
3-39-15 Showa-machi
Maebashi 371-8514 (Japan)
E-Mail yamaguti @ health.gunma-u.ac.jp
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Maki et al.: Symptoms of Early Dementia-11 Questionnaire (SED-11Q): A Brief
Informant-Operated Screening for Dementia

when they are at the early stages of disease [2]. For early detection of dementia, a rapid
screening test in clinical settings would be extremely useful, as it could help general practi-
tioners with time constraints to decide whether or not to proceed with more in-depth clinical
evaluation. Such a screening test is also useful for community health promotion to detect
undiagnosed individuals.
An ideal practical screening test should be easy to administer within tight time constraints
but must also be accurate enough to detect dementia. There are two general methods to
screen for dementia: patient performance-based testing and informant interviews.
Regarding patient performance-based testing, the most widely used brief test is the Mini-
Mental State Examination (MMSE) [3]. However, this test is time-consuming to administer in
a clinical setting with time constraints. Furthermore, the ceiling effect makes the MMSE insen-
sitive to the early stages of dementia [4], especially for highly educated individuals [5, 6]. In
contrast, a brief test such as the MMSE may falsely identify those with low education or poor
cognitive functioning as demented. Other brief tests have also been developed. However,
because of the requirement of brevity, most of them are limited to a single cognitive domain.
For instance, the tests that are weighted towards memory such as the Short Blessed Test [7]
and the Memory Impairment Screen [8] may not be sensitive enough for detecting nonam-
nestic dementias. Another problem is the psychological burden imposed by cognitive tests,
as cognitive tests for dementia are themselves stressful [1].
In the community-based setting, performance-based tests may be impractical for
detecting underdiagnosed dementia. A lack of self-awareness of cognitive decline is a charac-
teristic of dementia [9, 10], and demented individuals tend to deny their cognitive decline and
refuse the test. Ethical issues are also important; using screening tests with low specificity
could lead to a misdiagnosis of dementia in elderly individuals, which could cause unnec-
essary anxiety. The detection of dementia should be conducted without unduly alarming the
patient. In this respect, informant-based assessments are preferable.
When evaluating informant-based assessments, the Clinical Dementia Rating scale (CDR)
[11] is widely used. CDR meets the requirement of accuracy, but it is not an easily adminis-
tered screening tool. It is a semistructured interview that has to be carried out by trained
practitioners and takes at least 30 min.
In the present study, we introduce a brief informant-based screening questionnaire to
identify dementia in both clinical and community-based settings, namely the Symptoms of
Early Dementia-11 Questionnaire (SED-11Q). This questionnaire is easily administered and is
both patient and informant friendly. Questions addressing early signs of dementia were selected
on the basis of clinical experience. The SED-11Q aims to investigate the state of ordinary daily
activities often performed by an elderly individual living independently. The questions it asks
are not only easy to answer, but are also informative. Quantifying difficulties in daily living may
provide more sensitive information about early functional changes rather than questions about
cognitive function in a single domain. This is because functional integrity is a key differentiating
feature of dementia, and a decline in multifaceted cognitive domains directly leads to functional
impairments. In addition, as deficits caused by dementia are manifested in various aspects, the
SED-11Q also includes questions on social interaction and personality.

Methods

459 elderly individuals participated, including 39 with mild cognitive impairment (MCI)
in CDR 0.5, 233 with mild dementia in CDR 1, 106 with moderate dementia in CDR 2, and 81
normal controls in CDR 0. The demented individuals were outpatients, and of the 81 normal
controls, 64 were community dwellers and 17 were outpatients (table 1). The subjects were
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Maki et al.: Symptoms of Early Dementia-11 Questionnaire (SED-11Q): A Brief
Informant-Operated Screening for Dementia

Table 1. Demographic data

CDR 0 CDR 0.5 CDR 1 CDR 2

(n = 81) (n = 39) (n = 233) (n = 106)

Age, years 71.7 ± 6.0 78.7 ± 6.9 79.6 ± 9.7 79.5 ± 13.2
Gender (male/female) 74/7 18/21 82/151 29/77
MMSE 28.5 ± 2.1 26.4 ± 2.2 21.1 ± 4.2 16.1 ± 4.2
SED-11Q 1.00 ± 1.29 3.21 ± 2.14 5.71 ± 2.78 7.25 ± 2.88
Causative diseases
AD 5.76 ± 2.76 (127) 6.95 ± 2.79 (40)
Others 5.66 ± 2.81 (106) 7.44 ± 2.93 (66)

With the exception of gender (number of patients) values represent mean ± SD. Values in parenthe-
ses represent the number of patients. The ages were significantly different between the groups (p < 0.001).
CDR 0 was detected significantly more frequently in the younger groups. There was no difference between
the affected groups of CDR 0.5, CDR 1, and CDR 2.

diagnosed based on criteria for dementia diseases such as NINCDS-ADRDA for AD [12], the
third report of the Dementia with Lewy Bodies Consortium for Lewy body dementia [13],
criteria by Neary et al. [14] for frontotemporal lobar degeneration, criteria by the NINDS-
AIREN International Workshop for vascular dementia [15], and MCI by the report of the Inter-
national Working Group on Mild Cognitive Impairment [16]. CDR 0.5 was regarded as MCI,
although a different classification was proposed, whereby CDR 0.5 encompasses both mild
and earlier dementia [17] or it corresponds to very mild dementia [18]. Depression was an
exclusive criterion for normal controls in CDR 0 and subjects with MCI in CDR 0.5. The ethics
board of the Gunma University School of Health Sciences approved all procedures (No. 21–27),
and written informed consent was obtained from the participants.
Originally, the questionnaire consisted of 13 questions, which are shown in table 2. In the
clinical and community setting, the informants were required to fill out the questionnaire
including the 13 items. Based on the results of the current study, we decided to exclude
2 items: item 2 (misplacing) and item 13 (delusions). The format of the SED-11Q is shown in
figure 1. In the present study, informants were limited to family members, and nonfamily
caregivers were excluded. Informants had normal cognitive abilities without psychiatric
diseases, delirium, or verbal incomprehension including aphasia.
The patients were also tested using the MMSE. All analyses were conducted using the
Japanese version of SPSS for Windows version 19.0 (IBM Corp., New York, N.Y., USA). Signifi-
cance was set at p < 0.05.

Results

Demographic data are shown in table 1. The ratio of positive answers in subitems in the
quotient is shown in figure 2. In CDR 0, 51% checked item 2, whereas no one checked items
7 and 13. In CDR 1, more than 50% checked items 1, 2, 3, 6, 8, 9, 10, and 11. Sensitivities and
specificities of the subitems in CDR 0 and CDR 1 are shown in table 2. Item 2 (misplacing)
showed the lowest specificity, i.e. 0.49, out of the 13 items. Item 13 (delusions) showed the
lowest sensitivity, i.e. 0.18, although the specificity was 1. Therefore, these 2 items were
removed in the SED-11Q. Instead, a notification was added to recommend medical consul-
tation whenever delusions or illusions were detected.
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Maki et al.: Symptoms of Early Dementia-11 Questionnaire (SED-11Q): A Brief
Informant-Operated Screening for Dementia

Table 2. Sensitivity and

Item Sensitivity Specificity
specificity of the 13 subitems in
the differentiation between CDR
1 Repetitive talking 0.81 0.79
0 and CDR 1 2 Misplacing 0.85 0.49
3 Context understanding 0.52 0.99
4 Indifference about clothing 0.31 0.91
5 Cleaning up 0.35 0.91
6 Forgetting one of two items 0.60 0.90
7 Self-medication 0.47 1.00
8 Time consuming 0.62 0.88
9 Planning 0.52 0.98
10 Complex topics 0.64 0.93
11 Loss of interest 0.54 0.93
12 Irritable and suspicious 0.33 0.81
13 Delusions 0.18 1.00

Scores were as follows: 1.00 ± 1.29 (mean ± SD) in CDR 0, 3.21 ± 2.14 in CDR 0.5, 5.71 ±
2.78 in CDR 1, and 7.25 ± 2.88 in CDR 2. There was a significant difference among the CDR
groups [analysis of variance F(3, 455) = 106.264, p < 0.001], and post hoc analysis with
Bonferroni correction indicated the following significant differences: CDR 2 higher than
CDR 1, CDR 1 higher than CDR 0.5, and CDR 0.5 higher than CDR 0 (p < 0.001). Modes of the
scores were 0 in CDR 0, 2 in CDR 0.5, 5 in CDR 1, and 9/10 in CDR 2 (fig. 3).
Comparing CDR 0 and CDR 1 in the SED-11Q, the area under receiver operating charac-
teristic (ROC) curve was 0.932 [p < 0.001, 95% confidence interval (CI): 0.903–0.961]. A
cutoff value of 2/3 indicated a sensitivity of 0.841 (95% CI: 0.817–0.857), a specificity of
0.901 (95% CI: 0.830–0.947), a positive predictive value of 0.961 (95% CI: 0.933–0.979), and
a negative predictive value of 0.664 (95% CI: 0.611–0.697). A cutoff value of 3/4 indicated a
sensitivity of 0.764 (95% CI: 0.743–0.772), a specificity of 0.963 (95% CI: 0.903–0.987), a
positive predictive value of 0.983 (95% CI: 0.957–0.994), and a negative predictive value of
0.586 (95% CI: 0.550–0.601) (fig. 4). The correlation coefficient of the SED-11Q and the MMSE
was significant: r = –0.424 and r < 0.001.

Discussion

The SED-11Q reliably differentiated nondemented from demented individuals. The area
under the ROC curve was 93%, suggesting good discrimination between the 2 groups. In the
clinical setting with physicians and other medical staff, the statistically optimal cutoff value
of 2/3, which indicates a sensitivity of 0.841 and a specificity of 0.901, can be applied. In the
community setting, where community-dwelling elderly individuals are screened for detecting
dementia, a cutoff value of 3/4, which indicates a sensitivity of 0.764 and a specificity of 0.963,
is recommended because of high specificity and positive predictive values. Medical consul-
tation is recommended whenever delusions or illusions are detected. In general, the SED-11Q
was revealed to be practical as a rapid screening tool in general practice to decide whether
or not to seek further diagnostic confirmation.

Consideration of Subitems
The 2 items that assessed memory function, item 1 (repetitive talking) and item 2
(misplacing), showed high sensitivities of 0.8 and more comparing CDR 0 to CDR 1. Amnestic
disorder is one of the earliest signs of AD, and the reason for this could be the fact that the
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Maki et al.: Symptoms of Early Dementia-11 Questionnaire (SED-11Q): A Brief
Informant-Operated Screening for Dementia

Fig. 1. Format of the SED-11Q. The questionnaire represents an informant-based screening and should not
be used as a patient-completed screening questionnaire. The total SED-11Q score is the sum of the items
marked ‘Yes’.
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Maki et al.: Symptoms of Early Dementia-11 Questionnaire (SED-11Q): A Brief
Informant-Operated Screening for Dementia

Fig. 2. The ratio of positive answers in the subitems (quotients) according to the CDR groups.

majority of the patients were those with AD in the present study. Item 2 (misplacing) was
excluded from the SED-11Q because the specificity was 0.49, which suggested a danger of
false positivity.
In CDR 1, deficits in instrumental activities of daily living (IADL) become obvious. In the
present study, 4 items, item 3 (context understanding), item 6 (forgetting one of two items),
item 8 (time-consuming), and item 9 (planning), showed sensitivities of 0.5 and more and
specificities of 0.85 and more in the comparison between CDR 0 and CDR 1. It becomes difficult
for the patients in CDR 1 to function independently, even if compensatory strategies are
employed, and deficits can be noticed in cooperative activities and conversations in daily
living.
The other 2 items regarding IADL, item 4 (indifference about clothing) and item 5
(cleaning up), showed sensitivities of less than 0.5, while specificities were 0.9 and more in
the comparison between CDR 0 and CDR 1. It is possible that informants tend to pay little
attention and overlook the deficits because of slow and gradual changes. These items remained
in the list, considering a community-based use, as it could help elderly individuals if symptoms
of dementia other than memory deficits are detected by using the questionnaire. Item 4 (indif-
ference about clothing) could gradually lead to an apathetic attitude to life, which is one
of the psychological behavioral symptoms of dementia and aggravates cognitive function.
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Maki et al.: Symptoms of Early Dementia-11 Questionnaire (SED-11Q): A Brief
Informant-Operated Screening for Dementia

Fig. 3. Distribution according to

the severity of dementia. The dis-
tribution is shown in the quo-
tients. Modes of scores were 0 in
CDR 0, 1 in CDR 0.5, 5 in CDR 1,
and 9/10 in CDR 2.

Fig. 4. The ROC curve of the SED-

11Q in the differentiation be-
tween CDR 0 and CDR 1. The area
under the curve is 0.932 (p <
0.001, 95% CI: 0.903–0.961). The
statistically optimal cutoff value
of 2/3 indicated a sensitivity of
0.841 and a specificity of 0.901.
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Maki et al.: Symptoms of Early Dementia-11 Questionnaire (SED-11Q): A Brief
Informant-Operated Screening for Dementia

Item 5 (cleaning up) is a typical behavior of demented individuals with attentional deficits
and difficulties in executive function.
A relatively low sensitivity of 0.47 in item 7 (self-medication) is rather unexpected,
because previous studies suggested that self-medication is one of the early signs of dementia
[19–24]. Possible causes for this discrepancy could be that some patients may have developed
long-term habits of medication, e.g., antihypertensive drugs, while others may not have taken
any medications, as the questionnaire was filled out at the initial visit. A specificity of 100%
suggested that self-medication could be a robust sign of dementia, and follow-up is needed to
observe whether those already affected by dementia can acquire a habit of self-medication
or not.
For item 10 (complex topics), cognitive decline is associated with difficulties in social
interaction. Socially active lifestyles have a protective influence on mental decline: social
isolation is associated with an increased risk of mental decline [25, 26], whereas a rich social
network and interaction may protect against mental decline [27, 28]. It becomes difficult for
patients to maintain socially active lives, and thus it is desirable that families and caregivers
help the patients keep up social interaction.
Changes in interests are also characteristic of the early stages of dementia, as assessed
by item 11 (loss of interest) in this questionnaire. Due to cognitive decline, patients are
confronted with the loss of mental capacity. They have difficulty in doing what they could
easily do and have enjoyed doing previously. Consequently, they lose their motivation and
tend to be apathetic. Item 11 (loss of interest) is also related to social interaction; it becomes
difficult to maintain social interaction even with those sharing the same hobbies. Families and
caregivers should watch for changes because apathy and inaction are related to increased
functional disability [29].
Personal changes are also observed in individuals with dementias other than AD, and the
SED-11Q aims to detect these dementias. Item 12 asks about changes relating to irritability
and suspicion, which are observed in frontotemporal lobar degeneration and are early signs
of disease. Items 4 and 11 are associated with apathetic changes, which are more prominent
in vascular dementia than in AD [30]. These 2 items could lead to depressive tendencies,
which is a frequent symptom of Lewy body dementia [31].
Concerning item 13 (delusions), sensitivity was low, whereas specificity was 100%. Thus,
it could be regarded as a determining factor in the diagnosis of dementia or other psychiatric
diseases. In the SED-11Q, item 13 was excluded and notification was added to recommend
medical consultation whenever delusions or illusions are detected.

Discriminative Ability of the SED-11Q

In the clinical setting, a statistically optimal cutoff value of 2/3 can be applied, whereas
in the community setting, a cutoff value of 3/4 is recommended (fig. 4). In the clinical setting,
medical staff can determine whether the informants are reliable or not, and they can interview
the informants and patients if necessary, whereas in the community setting, such screening
is often conducted without medical staff.
In general, during screening, false positives may be preferable to false negatives because
failure of early detection could result in a lack of early intervention. However, considering the
characteristics of dementia, false negatives are preferable in brief screening. Disease-modi-
fying drugs have not been developed and cognitive and functional capacity would inevitably
decline as the disease progresses. The US Preventive Services Task Force (USPSTF) warned
that labeling an individual with dementia could potentially cause unnecessary anxiety, which
is a risk factor for cognitive decline [32]. Therefore, physicians should perform a careful
examination to make a definitive diagnosis, but cognitive tests for dementia are inherently
potentially stressful. In this way, not only an incorrect diagnosis of dementia, but also the
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Maki et al.: Symptoms of Early Dementia-11 Questionnaire (SED-11Q): A Brief
Informant-Operated Screening for Dementia

notification of the probability of dementia could lead to negative psychosocial consequences.

Thus, it makes sense to value specificity more than sensitivity, especially in community
settings.
The SED-11Q should not be used to detect MCI (CDR 0.5), as the screening of asymp-
tomatic stages should be conducted carefully. The results of the present study showed a wide
distribution of scores in CDR 0.5, and considering the negative psychosocial consequences
which result from a false-positive judgment, a diagnosis of MCI should be carefully made.

Self-Rating Scales
Self-rating scales are not appropriate to detect dementia, because subjective cognitive
impairment and memory complaints are common in elderly individuals [33–36]. It is contro-
versial whether subjective complaints are associated with cognitive decline [37, 38], and it
has been reported that such complaints are correlated with depressive symptoms or person-
ality traits, rather than cognitive decline [39, 40]. In addition, those who are already demented
tend to overestimate their functions, and their self-awareness of cognitive impairments
diminishes as disease progresses, especially in memory [9, 10].

Other Informant-Based Questionnaires

Other informant-based questionnaires have been developed. In 1989, the Informant
Questionnaire on Cognitive Decline in the Elderly (IQCODE; available in 26- and 16-item
formats) [41] was proposed. It requires an intrapersonal comparison between the present
states and those of 10 years ago. However, memories of 10 years ago are vague, and normally
aging individuals experience cognitive declines. Thus, the IQCODE can result in false-positive
diagnoses, and age-related changes are often misdiagnosed as symptoms of dementia.
Furthermore, the IQCODE includes questions on symptoms associated with rather advanced
stages, e.g., not recognizing the faces of family members, not remembering the names of
family members, not remembering things that happened to him/her when he/she was young,
and not remembering things he/she learned when he/she was young.
Another example is the Observation List of Possible Early Signs of Dementia (OLD) [42].
This test focuses on cognitive decline, and questions about daily functioning are not included.
Combined questionnaires that ask about cognitive function and daily functioning are desirable
[43], as daily functioning requires multifaceted cognitive abilities, and deficits in functional
integrity represent a key feature of dementia.
A brief scale combining a single-item informant report of memory problems and a 4-item
IADL scale has also been proposed [44]. Although the test itself is easy and brief, the scoring
system is complicated and arbitrary, and the test has not been validated with a large cohort.
Another scale that combines questions on cognitive abilities and daily functioning is the
8-item questionnaire, AD8 [43]. AD8 consists of questions about the patient’s memory, orien-
tation, and functional abilities by placing emphasis on intraindividual, rather than interindi-
vidual comparisons. However, the time frame for change is set as the last several years (an
exact time frame is not required). Most of the informants whom we meet in daily practice tend
to overlook longitudinal change. It would be more practical to ask about the patient’s state
during a short period, such as the last month. The validity and reliability were confirmed in
early dementia; a score of 2 or more points suggested that cognitive impairment is likely
present with a sensitivity over 84% and a specificity over 80%. The negative predictive value
was around 70%, and thus there is a risk of overdiagnosis. AD8 was also recommended for
detection of MCI, but screening of MCI using such brief tests could result in unnecessary false-
positive judgment, as stated above. In the absence of informants, the authors recommend AD8
as a self-completion questionnaire, as they reported that self-rating of AD8 differentiated
nondemented from demented individuals with the same specificity as informant ratings [45].
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Maki et al.: Symptoms of Early Dementia-11 Questionnaire (SED-11Q): A Brief
Informant-Operated Screening for Dementia

However, the results have not been validated in other cohorts. As stated above in the ‘Self-
rating scales’ section, it is debatable whether self-ratings should be considered as reliable as
informants’ reports.

Limitations
Reliable informants are not always available. In cases with no reliable informants, a
detailed medical interview and examination should be conducted. It is inadvisable to rely on
data derived from the SED-11Q when it has been used for self-rating for the reasons stated
above. Moreover, it should be noted that scores can be biased by informant depression, care
burden, and the relationship with the patient. False positivity is possible for those with
depression, as depression, even without comorbid dementia, causes cognitive deficits. It
might be necessary to rule out depression at the initial screening using the SED-11Q. Differ-
entiation of dementia from depression requires careful examination, and depression itself is
an important risk factor for dementia [46–48]. Another limitation is that this study included
few cases of dementias other than AD, and samples should be collected to confirm the reli-
ability of this test in other dementias.
The questionnaire should be validated in a multisite study in both practical and commu-
nity settings.

Acknowledgements

The authors thank all the study participants, Dr. Masamitsu Takatama (Geriatrics
Research Institute and Hospital, Maebashi), and Rumi Shinohara and Yuko Tsunoda (Gunma
University, Maebashi) for their support. Dr. Haruyasu Yamaguchi was supported by a Grant-
in-Aid for Scientific Research from the Ministry of Education, Science, Sports, Culture, and
Technology, Japan (23300197 and 22650123) and a Grant-in-Aid for Scientific Research
(H22-Ninchisho-Ippan-004) from the Ministry of Health, Labor, and Welfare, Japan.

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