2008 California Guideline for Alzheimer’s Disease Management Debra Cherry, PhD Alzheimer’s Association, California Southland Brad Williams, PharmD, CGP USC School of Pharmacy
Dec 27, 2015
2008
California Guideline for Alzheimer’s
Disease Management
Debra Cherry, PhD Alzheimer’s Association,
California Southland
Brad Williams, PharmD, CGP USC School of
Pharmacy
Objectives
• Describe the process utilized to update the California Guideline for AD Management
• Review the Guideline’s recommendations• Apply the recommendations to patients and
caregivers• Use the Guideline to implement a quality
improvement project
History of California AD Management Guideline
• 1995: California Workgroup on Guideline for Alzheimer’s Disease Management formed
• 1998 Publication of the first Guideline
• 2002 Guideline updated & published in The American Family Physician
• 2008 Third update completed.
Composition of the California Workgroup
Representatives from throughout the State:• Healthcare providers• Consumers• Academicians• Professional and volunteer organizations
Purpose of the Guideline
Represents core care recommendations for AD management which are:
• Based on scientific evidence• Supplemented by expert consensus• General guide to post-diagnostic
care• Intended for Primary Care
Practitioners including:– Physicians– Nurse Practitioners/Nurses– Physician Assistants
•Also defines a role for:–Social Workers–Care Managers
Mrs. R. L.
Mrs. R. L. is a retired librarian who visits her physician for a routine follow-up for her osteoarthritis, GERD, and glaucoma. She has enjoyed her 3 years of retirement, but reports that recently her husband has been worried about her memory. Mrs. L. states that she had started writing reminder notes, “which don’t always help.” She admits to reading less than she used to; she also drives less because “traffic is such a problem.”
Mrs. R. L.
Mr. L. reports that his wife often returns from grocery shopping having forgotten to pick up several things that she intended to buy. At other times she will wander through the house, looking in drawers or closets for items that she had put away for safe-keeping. Although they used to go out to dinner at least once a week, they now go much less frequently because Mrs. L. states that “I just never know what to order, and it’s not as much fun as it used to be.”
Dementia Warning Signs
Task Example
Memory decline Forgetfulness
Difficulty performing familiar tasks
Bill paying, shopping
Disorientation Getting lost in familiar places
Impaired judgment Inviting strangers into the home
Impaired abstract thinking, problem-solving
Driving skills
Dementia Warning Signs
Task Example
Misplacing things Losing valuable items in the home
Mood or behavior change
New-onset irritability, unusual habits or activities
Personality change Withdrawn, increased socialization
Problems with language Word finding difficulties
Guideline for AD Management
• Assessment• Treatment• Patient & Family Education & Support• Legal Considerations
Assessment
• Cognitive status• Daily function• Concurrent medical conditions• Medications• Behavior symptoms and mood• Living arrangements• Support system
Assessing Cognition
Test Items/Score Domains
Folstein Mini-Mental Status Exam
19 items
30 points
Multi-dimensional
Mini-Cog 2 items
5 points
3-item recall
Clock drawing
Blessed Orientation-Concentration-Memory
6 items
28 points
Orientation, concentration, recall
Cognitive Assessment Screening Instrument
25 items
100 points
Multi-dimensional
Assessment: Function Activities of Daily Living (ADL)
• Self-feeding• Dressing• Ambulation• Toileting
• Bathing• Transfer from bed to
toilet• Continence• Grooming• Communication
Assessment: FunctionInstrumental ADL (IADL)
• Writing• Reading• Cooking• Cleaning• Shopping• Doing laundry
• Climbing stairs• Using telephone• Managing medication• Managing money• Ability to perform outside
work• Ability to travel (public
transportation)
Assessment: Concurrent Conditions
• Chronic disease– Ability to manage
• Acute Conditions– Delirium– Infection/UTI/Influenza
Assessment: Medications & Cognition
• Anticholinergics• Benzodiazepines• Sleep aids• Antipsychotics• Narcotics• Muscle relaxants
• NSAIDs• Anti-arrhythmics• Antihypertensives• Cimetidine• Corticosteroids• Hypoglycemic agents
Assessment: Behavior & Mood
• Agitation– Restlessness
– Irritability
– Aggression
• Psychosis– Delusions
– Paranoia
– Hallucinations
• Depression– Withdrawal
– Sleep disturbances
– Appetite changes
• Apathy– Loss if interest
Assessment: Living Arrangements
• Declining ability for self-care– Patient autonomy vs. need for care
• Safety issues– Rugs, appliances– Driving
• Abuse and neglect– Dependence– Caregiver stress
Assessment: Support System
• Family’s ability to care for patient• Community supports
– Alzheimer’s Association– Caregiver Resource Center– Religious or other groups
• Community resources – day care, in-home care• Health care resources• Advance directives
Mrs. R has come to the USC Alzheimer’s Disease Center and been thoroughly assessed. She has been determined to have a diagnosis
of Alzheimer’s disease. What next?
Treatment: Develop a Treatment Plan
• Improve cognitive function
• Increase level of function
• Delay disease progression
• Manage behavior disturbances
• Ease caregiver burden
Treatment: Improve Cognitive Function
• Cholinergic manipulation– Cholinesterase inhibitors
• All agents block acetylcholinesterase activity• Rivastigmine also blocks butyrylcholinesterase• Galantamine stimulates cholinergic receptors
• NMDA antagonist– Reduces glutamate activity– Regulates calcium entry into cells
Donepezil (Aricept®)
• Approved for all stages of AD
• Availability– 5 & 10 mg tablets
– 5 & 10 mg ODT
– 1 mg/mL solution
• Dosing– 5 mg is therapeutic
– May increase to 10 mg after 4-6 weeks
• May be given without regard to food
• CYP1A2 substrate
Galantamine (Razadyne®)
• Approved for mild, moderate AD
• Availability– 4, 8, 12 mg tablets
– 8, 16, 24 mg ER capsules
– 4 mg/mL solution
• Will be first ChEI to go generic
• Dosing– Initial daily dose of 8 mg is not
therapeutic
– Dose escalation is 8 mg/day in 4-6 week intervals
– Maximum is 24 mg/day
• Give with meals
• Elimination– 50% renal
– 2D6/3A4 substrate
Rivastigmine (Exelon®)
• Approved for mild, moderate AD
• Availability– 1.5, 3, 4.5, 6 mg
capsules
– 4.6, 9.5 mg/24 hr transdermal patch
– 2 mg/mL solution
• Dosing– Initial dose of 1.5 mg twice daily is
not therapeutic
– Dose escalation is 1.5 mg twice daily in 4-6 week intervals
– Maximum is 12 mg/day
– Initial patch dose of 4.6 mg/24 hours is therapeutic
• Must give with meals
• Renal excretion
Principles for ChEI Use
• Initial treatment upon diagnosis or 6-months duration of AD symptoms
• Evaluate for ADR after 2-4 weeks
• Evaluate for effectiveness every 6 months– Switch if poor
tolerance, or continued decline
• Discontinue prior to surgery
Counseling Points
• Effects on cognition are very mild– May stabilize or slow decline for 6-12 months
• May improve independence, self-care• Gastrointestinal effects are prominent• May slow heart rate
The Evidence Suggests…
-Kaduszkiewicz, et al., BMJ 2005;331:321-327
Conclusion Because of flawed methods and small clinical benefits, the scientific basis for recommendations of cholinesterase inhibitors for the treatment of Alzheimer’s disease is questionable.
Memantine (Namenda®)
• Approved for use in moderate, severe AD– Monotherapy
– With ChEI
• Availability– 5 & 10 mg tablets
– 10 mg/5 mL solution
• Dosing– 5 mg/day for 1 week
– Increase by 5 mg/day in weekly intervals to 10 mg twice daily
– 10 mg/day maximum with renal impairment
• May be taken without regard to meals
• Renal elimination as unchanged drug
Memantine Adverse Effects
• > 5% incidence in clinical trials– Agitation (less than for placebo)– Diarrhea– Insomnia
• 5% incidence– Dizziness– Headache– Hallucinations
Memantine
• Effects in moderate AD– Slower decline in overall function and in loss of
activities of daily living– No significant effect on cognition
• Systematic reviews have reported small to no clinically relevant effect
TREATMENTRecommendations (cont.)
• Treat behavioral symptoms and mood disorders using:
– Non-pharmacologic approaches, such as environmental modification, task simplification, appropriate activities, etc.
• IF non-pharmacological approaches prove unsuccessful, THEN use medications, targeted to specific behaviors, if clinically indicated. Note that side effects may be serious and significant.
Treatment: Behavior Symptoms
• Most difficult for both patients and caregivers
• Behavior symptoms contribute to:– Patient distress– Caregiver burnout– Excess disability– Institutionalization
Treatment: Increase level of function and delay disease progression
• Behavioral Interventions• Medications• Adult Day Services• Exercise and Recreation
Jost BC, Grossberg GT. J Am Geriatr Soc. 1996;44:1078-1081.
Agitation
Diurnal Rhythm
Irritability
Wandering Aggression
Hallucinations
Mood Change
Socially Unacceptable
Delusions
Sexually InappropriateAccusatorySuicidal
Ideation
Paranoia
Depression
100
80
60
40
20
0–40 –30 –20 –10 0 10 20 30
Months Before Diagnosis Months After Diagnosis
Pre
vale
nce
(%
of
pat
ien
ts)
AnxietySocial Withdrawal
Behavioral Symptoms as AD Progresses
Mrs. R. L.
Some time has passed and Mr. L. is concerned about changes in his wife’s behavior. She becomes agitated, especially in the late afternoon and leaves the house. She says she is going home and gets more agitated when he reminds her that she is in her home.
Evaluating Behaviors
• Rapid onset requires search for medical cause– Pain, infection, adverse drug effect
• Identify problema. Behavior triggers
b. Specific Behaviors
c. Consequences
Common Causes of Behaviors
• Health problems
• Difficult tasks
• Confusing environment
• Communication breakdown
• Patient’s perceptions of the situation
What may be triggering Mrs. L.’s behavior?
What does this behavior mean to her?
How should these symptoms be managed?
Behavior Management Principles
• Non-drug management generally provides better results
• Assess likelihood that pharmacotherapy will be beneficial– Target medication to specific behavior– Avoid caregiver interpretation of PRN orders– Consider the patient's health status– Consider drug pharmacokinetic and
pharmacodynamic properties
Mrs. R. L.
Mrs. R. L. has begun a daily exercise program and late afternoon agitation is now less of an issue. However, at night she awakens and becomes agitated. She believes someone is trying to break into the house. When her husband tries to reassure her, she gets angry and strikes out at him.
What non-drug strategies are appropriate to manage Mrs. L.’s current behaviors?
Is drug therapy appropriate, and if so, how should it be initiated?
PATIENT and FAMILY EDUCATION & SUPPORT
Recommendations
• Integrate medical care with education & support by connecting patient & caregiver to support organizations
- Alzheimer’s Association 1-800-272-3900 www.alz.org
- Family Caregiver Alliance 1-800-445-8106
www.caregiver.org- or your own social service department.
PATIENT and FAMILY EDUCATION & SUPPORT
Early Stages
Pay particular attention to the special needs of early-stage patients, involving them in care planning, heeding their opinions and wishes, and referring them to community resources, including the Alzheimer’s Association.
LEGAL CONSIDERATIONSRecommendations
• Include a discussion of the importance of basic legal and financial planning as part of the treatment plan as soon as possible after the diagnosis of AD.
• Monitor for evidence of and report all suspicions of abuse as required by law.
• Report the diagnosis of AD in accordance with local laws.
Using the Guideline in a Health Care Setting
Health care organizations are challenged to care
for the growing number of older adults with
chronic health conditions
How to use Guidelines for a QI project:
• Set quality goals derived from guideline
• Train practitioners
• Add case management
• Evaluate
Implementation Support Tools
Provider Tool Kit
• Medical Record Checklist
• List of Reversible Medical Conditions
• Signs/Symptoms of Elder Abuse
• Mental Status Exam
• Safe Return / ID Bracelet Program Application
• Dementia and Driving Reporting Law
• Prescription Pad
QI Projects Using Guidelines
• Kaiser Permanente – Metro L.A.
• ACCESS – Kaiser, Scripps &
U.C.S.D. Healthcare
• HealthCare Partners Medical Group
• SCAN HealthPlan
Establishing Partnerships Replication Manual
Based on Alzheimer’s Association – Kaiser Permanent Metropolitan Los Angeles Dementia Care Project
www.alz.org/californiasouthland Click on Professional Training then Replication Manual
Got Guideline?2008 California Guideline for Alzheimer’s Disease
Management
Available at:
www.caalz.org(you can put your own website information here)
323-930-6289(you can put your own contact person here)