• Scottish Intercollegiate Guidelines Network (SIGN). Management of patients with dementia. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2006 Feb. 53 p. (SIGN publication; no. 86). [183 references]

Dementia

Note: This guideline does not address mild cognitive impairment, palliative care in advanced disease, risk, or prevention.

Diagnosis
Evaluation
Treatment

Family Practice
Geriatrics
Internal Medicine
Neurology
Psychiatry
Psychology

Advanced Practice Nurses
Nurses
Occupational Therapists
Physical Therapists
Physician Assistants
Physicians
Psychologists/Non-physician Behavioral Health Clinicians

• To present evidence-based recommendations for the management of dementia
• To consider investigations and interventions in which direct benefit to the patient can be demonstrated

Patients with all stages of dementia excluding mild cognitive impairment

Diagnosis

1. Detailed medical history including mode of onset, course of progression, pattern of cognitive impairment, presence of behavioural disturbances, hallucinations, and delusions
2. Diagnosis using Diagnostic and Statistical Manual, 4^th edition (DSM-IV) and other scales for differential diagnosis of dementia
3. Cognitive testing using Mini-Mental State Examination (MMSE) and Adenbrooke's Cognitive Examination (ACE)
4. Screening for comorbid conditions
5. Imaging techniques such as computed tomography (CT) and single photon emission controlled tomography (SPECT)
6. Neuropsychological testing

Treatment

1. Non-pharmacological interventions including:
   • Behaviour management
   • Caregiver intervention programmes
   • Cognitive stimulation
   • Reality orientation therapy
   • Recreational activities

   Note: The following non-pharmacological interventions are considered, but the evidence to support their use is mixed:

   • Aromatherapy
   • Environmental design
   • Light therapy
   • Multisensory stimulation
   • Music therapy
   • Physical activities
   • Simulated presence
   • Validation therapy

   Note: The following non-pharmacological interventions were considered but not recommended:

   • Memory books
   • Reminiscence therapy

2. Pharmacological interventions including:
   • Antidepressants
   • Cholinesterase inhibitors (donepezil, galantamine, and rivastigmine)
   • Conventional antipsychotics (use with caution)

   Note: The following pharmacological interventions were considered but not recommended:

   • Anticonvulsants
   • Acetyl-L-camitine
   • Anti-inflammatories
   • Aspirin (with the exception of people with vascular dementia who have a history of vascular disease)
   • Benzodiazepines
   • Cerebrolysin
   • Ginkgo
   • Lecithin
   • Lithium
   • Melatonin
   • Memantine
   • Nicergoline
   • Oestrogen
   • Physostigmine
   • Salvia
   • Selegiline
   • Trazodone

• Accuracy of diagnostic testing
• Activities of daily living
• Symptoms of dementia including depression, behavioural disorders, and cognitive function
• Nursing home placement

Hand-searches of Published Literature (Primary Sources)
Searches of Electronic Databases

The evidence base for this guideline was synthesized in accordance with Scottish Intercollegiate Guidelines Network (SIGN) methodology. A systematic review of the literature was carried out using an explicit search strategy devised by a SIGN Information Officer. Databases searched include Medline, Embase, Cinahl, PsychINFO, and the Cochrane Library. The year range covered was 1997-2004. Internet searches were carried out on various websites including the New Zealand Guidelines Programme, NELH Guidelines Finder, and the US National Guidelines Clearinghouse. The Medline version of the main search strategies can be found on the SIGN website, in the section covering supplementary guideline material. The main searches were supplemented by material identified by individual members of the development group.

705

Weighting According to a Rating Scheme (Scheme Given)

Levels of Evidence

1++: High quality meta-analyses, systematic reviews of randomised controlled trials (RCTs), or RCTs with a very low risk of bias

1+: Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias

1-: Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias

2++: High quality systematic reviews of case control or cohort studies
High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal

2+: Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal

2-: Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal

3: Non-analytic studies (e.g., case reports, case series)

4: Expert opinion

Review of Published Meta-Analyses
Systematic Review with Evidence Tables

Expert Consensus

Grades of Recommendations

Note: The grade of recommendation relates to the strength of the evidence on which the recommendation is based. It does not reflect the clinical importance of the recommendation.

Grade A: At least one meta-analysis, systematic review of randomized controlled trials (RCTs), or RCT rated as 1++ and directly applicable to the target population; or

A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results

Grade B: A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 1++ or 1+

Grade C: A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 2++

Grade D: Evidence level 3 or 4; or

Extrapolated evidence from studies rated as 2+

Good Practice Points: Recommended best practice based on the clinical experience of the guideline development group.

The guideline developer reviewed one study that noted a cost savings of delay to institutionalisation as a result of caregiver training.

External Peer Review
Internal Peer Review

The national open meeting is the main consultative phase of the Scottish Intercollegiate Guidelines Network (SIGN) guideline development, at which the guideline development group presents its draft recommendations for the first time. The national open meeting for this guideline was held on 2 February 2004 and was attended by representatives of all the key specialties relevant to the guideline. The draft guideline was also available on the SIGN website for a limited period at this stage to allow those unable to attend the meeting to contribute to the development of the guideline.

This guideline was also reviewed in draft form by the independent expert referees, who were asked to comment primarily on the comprehensiveness and accuracy of interpretation of the evidence base supporting the recommendations in the guideline.

Note from the Scottish Intercollegiate Guidelines Network (SIGN) and National Guideline Clearinghouse (NGC): In addition to these evidence-based recommendations, the guideline development group also identifies points of best clinical practice in the full-text guideline document.

The strength of recommendation grading (A-D) and level of evidence (1++, 1+, 1, 2++, 2+, 2-, 3, 4) are defined at the end of the "Major Recommendations" field.

Diagnosis

History Taking and Differential Diagnosis

B - Diagnostic and Statistical Manual, 4^th edition (DSM-IV) or National Institute of Neurologic, Communicative Disorders and Stroke-Alzheimer's disease and related Disorders Association (NINCDS-ADRDA) criteria should be used for the diagnosis of Alzheimer's disease.

B - The Hachinski Ischaemic Scale or National Institute of Neurological Disorders and Stroke

Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS-AIRENS) criteria may be used to assist in the diagnosis of vascular dementia.

C - Diagnostic criteria for dementia with Lewy bodies and fronto-temporal dementia should be considered in clinical assessment.

Initial Cognitive Testing

B - In individuals with suspected cognitive impairment, the Mini-Mental State Examination (MMSE) should be used in the diagnosis of dementia.

Screening for Comorbid Conditions

B - As part of the assessment for suspected dementia, the presence of comorbid depression should be considered.

The Use of Imaging

C - Structural imaging should ideally form part of the diagnostic workup of patients with suspected dementia.

C - Single photon emission controlled tomography (SPECT) may be used in combination with computed tomography (CT) to aid the differential diagnosis of dementia when the diagnosis is in doubt.

The Role of Cerebrospinal Fluid and Electroencephalography

B - Cerebrospinal fluid (CSF) and Electroencephalography (EEG) examinations are not recommended as routine investigations for dementia.

Neuropsychological Testing

B - Neuropsychological testing should be used in the diagnosis of dementia, especially in patients where dementia is not clinically obvious.

Non-Pharmacological Interventions

Behaviour Management

B - Behaviour management may be used to reduce depression in people with dementia.

Caregiver Intervention Programmes

B - Caregivers should receive comprehensive training on interventions that are effective for people with dementia.

Cognitive Stimulation

B - Cognitive stimulation should be offered to individuals with dementia.

Reality Orientation Therapy

D - Reality orientation therapy should be used by a skilled practitioner, on an individualised basis, with people who are disorientated in time, place and person.

Recreational Activities

B - Recreational activities should be introduced to people with dementia to enhance quality of life and well-being.

Pharmacological Interventions

Cholinesterase Inhibitors

Donepezil

B - Donepezil, at daily doses of 5 mg and above, can be used to treat cognitive decline in people with Alzheimer's disease.

B - Donepezil, at daily doses of 5 mg and above, can be used for the management of associated symptoms in people with Alzheimer's disease.

Galantamine

B - Galantamine, at daily doses of 16 mg and above, can be used to treat cognitive decline in people with Alzheimer's disease and people with mixed dementias.

B - Galantamine, at daily doses of 16 mg and above, can be used for the management of associated symptoms in people with Alzheimer's disease.

Rivastigmine

B - Rivastigmine, at daily doses of 6 mg and above, can be used to treat cognitive decline in people with Alzheimer's disease.

B - Rivastigmine, at daily doses of 6 mg and above, can be used to treat cognitive decline in people with dementia with Lewy bodies.

B - Rivastigmine, at daily doses of 6 mg and above, can be used for the management of associated symptoms in people with Alzheimer's disease and dementia with Lewy bodies.

Antidepressants

D - Antidepressants can be used for the treatment of comorbid depression in dementia providing their use is evaluated carefully for each patient.

Antipsychotics

A - If necessary, conventional antipsychotics may be used with caution, given their side effect profile, to treat the associated symptoms of dementia.

Clinically Ineffective Interventions

Anti-Inflammatories

A - Anti-inflammatories are not recommended for treatment of cognitive decline in people with Alzheimer's disease.

B - Hydroxychloroquine is not recommended for the treatment of associated symptoms in people with dementia.

A - Prednisolone is not recommended for the treatment of associated symptoms in people with Alzheimer's disease.

Oestrogen

B - Oestrogen is not recommended for the treatment of associated symptoms in women with dementia.

Selegiline

A - Selegiline is not recommended for the treatment of core or associated symptoms in people with Alzheimer's disease.

Interventions Lacking Evidence of Clinical Effectiveness

Anticonvulsants

A - Valproate is not recommended for the treatment of behavioural symptoms associated with dementia.

Information for Discussion with Patients and Carers

Supportive Information for Patients and Carers

C - Patients and carers should be offered information tailored to the patient's perceived needs.

Disclosure of Diagnosis

C - Healthcare professionals should be aware that many people with dementia can understand their diagnosis, receive information and be involved in decision making.

C - Healthcare professionals should be aware that some people with dementia may not wish to know their diagnosis.

D - Healthcare professionals should be aware that in some situations disclosure of a diagnosis of dementia may be inappropriate.

Definitions:

Grades of Recommendations

Grade A: At least one meta-analysis, systematic review of randomized controlled trials (RCTs), or RCT rated as 1++ and directly applicable to the target population; or

A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results

Grade B: A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 1++ or 1+

Grade C: A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 2++

Grade D: Evidence level 3 or 4; or

Extrapolated evidence from studies rated as 2+

Levels of Evidence

1++: High quality meta-analyses, systematic reviews of randomised controlled trials (RCTs), or RCTs with a very low risk of bias

1+: Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias

1-: Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias

2++: High quality systematic reviews of case control or cohort studies
High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal

2+: Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal

2-: Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal

3: Non-analytic studies (e.g., case reports, case series)

4: Expert opinion

None provided

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

Appropriate diagnosis and management of patients with behavioural and psychological aspects of dementia

• Side effects of antipsychotics such as sedation, movement disorder and increased confusion are all recognised. Concern has been expressed that the use of these drugs accelerates decline in Alzheimer's disease but a causal effect has not been established.
• Although evidence supports the use of olanzapine and risperidone in the management of behavioural and psychological symptoms of dementias (BPSD), particularly psychosis and aggression, these drugs are not currently recommended by the Medicines and Healthcare products Regulatory Agency (MHRA) due to concerns about serious adverse events, particularly stroke.

Subgroups Most Likely to be Harmed

Practitioners should be aware that up to 60% of patients with dementia with Lewy bodies suffer adverse reactions to antipsychotic drugs.

This guideline is not intended to be construed or to serve as a standard of medical care. Standards of medical care are determined on the basis of all clinical data available for an individual case and are subject to change as scientific knowledge and technology advance and patterns of care evolve. Adherence to guideline recommendations will not ensure a successful outcome in every case, nor should they be construed as including all proper methods of care or excluding other acceptable methods of care aimed at the same results. The ultimate judgment must be made by the appropriate healthcare professional(s) responsible for clinical decisions regarding a particular clinical procedure or treatment plan. This judgement should only be arrived at following discussion of the options with the patient, family and carers, covering the diagnostic and treatment choices available. It is advised, however, that significant departures from the national guideline or any local guidelines derived from it should be fully documented in the patient's case notes at the time the relevant decision is taken.

Implementation of national clinical guidelines is the responsibility of local National Health Service (NHS) organizations and is an essential part of clinical governance. It is acknowledged that not every guideline can be implemented immediately on publication, but mechanisms should be in place to ensure that the care provided is reviewed against the guideline recommendations and the reasons for any differences assessed and, where appropriate, addressed. These discussions should involve both clinical staff and management. Local arrangements may then be made to implement the national guideline in individual hospitals, units and practices, and to monitor compliance. This may be done by a variety of means including patient-specific reminders, continuing education and training, and clinical audit.

Key areas to be considered for implementation are:

• The recognition of comorbid depression in dementia by primary care which will require significant training input
• The routine use of structural imaging which will require more access to imaging facilities given thenature of dementia and the prospect of treatment
• Widespread availability of information for patients and carers. This needs to extend beyond general practitioners' (GPs)' surgeries and appear in areas where older people go, such as libraries, post offices or supermarkets
• Clear strategies by NHS boards for the funding of cholinesterase inhibitors and associated infrastructure development of caregiver training programmes.

Key points for audit are identified in the original guideline document.

Living with Illness

Effectiveness
Patient-centeredness

• Scottish Intercollegiate Guidelines Network (SIGN). Management of patients with dementia. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2006 Feb. 53 p. (SIGN publication; no. 86). [183 references]

Not applicable: The guideline was not adapted from another source.

1998 Feb (revised 2006 Feb)

Scottish Intercollegiate Guidelines Network - National Government Agency [Non-U.S.]

Scottish Executive Health Department

Not stated

Guideline Development Group: Dr Peter Connelly (Chair) Consultant Old Age Psychiatrist, Murray Royal Hospital, Perth; Dr Carole Archibald, Associate Consultant/Trainer, Dementia Services Development Centre, University of Stirling; Dr Simon Backett, Consultant Old Age Psychiatrist, St John's Hospital, Livingston; Miss Jenni Brockie, Information Officer, SIGN; Dr Andrew Carnon, Consultant in Public Health Medicine, Dumfries and Galloway NHS Board; Dr Gisu Cooper, General Practitioner, Leith Walk Surgery, Edinburgh; Mrs Christina Cooper, Dementia Advocate, TODAY Group, Stratheden Hospital, Cupar; Ms Ann Fraser, Senior Physiotherapist, Royal Victoria Hospital, Edinburgh; Ms Eva Frigola Capell, Clinical Psychologist, Spain (SIGN Visiting Fellow); Dr John Greene Consultant Neurologist, Southern General Hospital, Glasgow; Professor Donald Hadley, Consultant Neuroradiologist, Southern General Hospital, Glasgow; Dr Roberta James, Programme Manager, SIGN; Ms Gail Kilbane, Service Manager, Alzheimer's Scotland, Action on Dementia, Kirkcaldy; Ms Caroline Lawrie, Charge Nurse, Bangour Village Hospital, Broxburn; Ms Margo Mason, Senior Occupational Therapist, Royal Victoria Hospital, Edinburgh; Mr Sandy McAfee, Consultant Clinical Psychologist, St John's Hospital, Livingston; Dr Gary Morrison, Consultant Psychiatrist, Crichton Royal Hospital, Dumfries; Ms Julie Penn, Memory Clinic Support Worker, Alzheimer's Scotland, Action on Dementia, Kirkcaldy; Dr Dan Rutherford, General Practitioner, Fife; Ms Sandra Stark, Nursing and Quality Consultant, Ardoch Consulting, Doune

Declarations of interests were made by all members of the guideline development group. Further details are available from the Scottish Intercollegiate Guidelines Network (SIGN) Executive.

This summary was completed by ECRI on February 6, 2002. The information was verified by the guideline developer as of April 9, 2002. This summary was updated by ECRI on April 7, 2006. The updated information was verified by the guideline developer on May 1, 2006. This summary was updated by ECRI Institute on October 2, 2007, following the U.S. Food and Drug Administration (FDA) advisory on Haloperidol. This summary was updated by ECRI Institute on November 9, 2007, following the U.S. Food and Drug Administration advisory on Antidepressant drugs. This summary was updated by ECRI Institute on January 10, 2008, following the U.S. Food and Drug Administration advisory on Carbamazepine. This summary was updated by ECRI Institute on July 25, 2008, following the U.S. Food and Drug Administration advisory on Antipsychotics.