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Severe Alzheimers Disease in the Institutional Setting: Treatment Challenges, Behavioral Issues, and Pharmacologic Management Strategies Focus on Patients.

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Presentation on theme: "Severe Alzheimers Disease in the Institutional Setting: Treatment Challenges, Behavioral Issues, and Pharmacologic Management Strategies Focus on Patients."— Presentation transcript:

1 Severe Alzheimers Disease in the Institutional Setting: Treatment Challenges, Behavioral Issues, and Pharmacologic Management Strategies Focus on Patients in the Assisted and Skilled Nursing Environment

2 Session Highlights Focus on institutionalized patients, mainly skilled nursing facilities Focus on institutionalized patients, mainly skilled nursing facilities Review demographics, and physical and psychiatric co- morbidities Review demographics, and physical and psychiatric co- morbidities Discuss disease characteristics and staging Discuss disease characteristics and staging Determine critical management issues for caregivers Determine critical management issues for caregivers Discuss clinical and pharmacoeconomic benefits of treatment Discuss clinical and pharmacoeconomic benefits of treatment

3 Payor statusMostly private andMostly Medicaid, private Third party. Some waiverminimal third party Medicaid PhysiciansMultiple PCPsMedical Directors and Few key attending CaregiversFamilyNursing staff AD stageEarly to moderateModerate to severe ComorbiditiesModerateMultiple Functional StatusSlight to moderately impaired Moderately to severely impaired GoalsImprove and maintain cognition Maintain ADLsSlow decline Slow behavior emergenceControl behaviorsCost Savings: Delay admission age in place Reduced staff time ALF SNF Characteristics of ALF vs. SNF

4 Dementia Prevalence in Primary and Long-Term Care Settings 75% of patients with moderate to severe dementia may go undiagnosed in the primary care setting 75% of patients with moderate to severe dementia may go undiagnosed in the primary care setting Almost 50% of residents admitted to long- term care (LTC) facilities have some degree of dementia Almost 50% of residents admitted to long- term care (LTC) facilities have some degree of dementia Up to three quarters of nursing home residents have dementia Up to three quarters of nursing home residents have dementia Magaziner J, et al. Gerontologist. 2000;40:663-672. Callahan CM, et al. Ann Intern Med. 1995;122:422-429.

5 MDS Cognitive Performance Scale (CPS) Derived from five questions directly from the Minimum Data Set (MDS) Derived from five questions directly from the Minimum Data Set (MDS) Validated as an accurate screening instrument in the skilled facility population in the geriatric literature Validated as an accurate screening instrument in the skilled facility population in the geriatric literature Positive correlation to the Mini Mental Status Exam (MMSE) Positive correlation to the Mini Mental Status Exam (MMSE) Morris JN, et al. MDS Cognitive Performance Scale. J Gerontol. 1994; 40:M172-M182.

6 Cognitive Performance Scale Comatose [MDS B1] Comatose [MDS B1] l 0 - no, l 1 - yes Short Term Memory OK [MDS B2a] Short Term Memory OK [MDS B2a] l 0 - memory okay l 1 - memory problem Cognitive Skills for Daily Decision Making [MDS B4] Cognitive Skills for Daily Decision Making [MDS B4] l independent l modified independence l moderately impaired l severely impaired

7 Cognitive Performance Scale (CPS) Communication/Hearing Patterns [C4] Communication/Hearing Patterns [C4] l 0 - understood l 1 - usually understood l 2 - sometimes understood l 3 - rarely/never understood Eating [MDS G1h] Eating [MDS G1h] l 0 - independent l 1 - supervision l 2 - limited assistance l 3 - extensive assistance l 4 - total dependence

8 Cognitive Performance Scale (CPS) Scoring System & Correlating Mini Mental Status Exam (MMSE) Score CPS SCORE CPS SCORE l 0 - Intact l 1 - Borderline Intact l 2 - Mild Impairment l 3 - Moderate Impairment l 4 - Moderately Severe Imp. l 5 - Severe Impairment l 6 - Very Severe Impairment MMSE SCORE (avg.) MMSE SCORE (avg.) l 24.9 l 21.9 l 19.2 l 15.4 l 6.9 l 5.1 l 0.4 Morris JN, et al. MDS Cognitive Performance Scale. J Gerontol. 1994;40: M172-M182.

9 Prevalence of Selected CNS Conditions from Admission MDS Files Percentage Alzheimers Dementia other than AD Schizophrenia Delusions/ Hallucinations Cognitive Impairment (CPS) None of the above 9.3% 20.9% 1.4% 27.1% 40.0% (N = 6,894 Residents)

10 Admission Cognitive Status of All Residents with Dementia (MDS Diagnosis or CPS > 2)

11 AIT Use in Residents with Admission Dementia (MDS Diagnosis or CPS > 2)

12 Pharmacologic Treatment Success in AD Treatment success may currently be defined as: Untreated/ natural course Stabilization Improvement Less-than expected decline Time Progression of Disease Change From Baseline

13 Galasko. Eur J Neurol. 1998;5(suppl 4):S9-S17. Activities of Daily Living (ADLs) Progressive Loss of Function MMSE Score Keep appointments Telephone Obtain meal/snack Travel alone Use home appliances Find belongings Select clothes Dress Groom 2520151050 02468 Years Maintain hobby Dispose litter Clear table Walk Eat Functional Loss Over the Course of AD

14 Benefits of Persistent Treatment: Delay in Nursing Home Placement Geldmacher DS, et al. J Am Geriatr Soc. 2003;51(5 Suppl Dementia):S289-S295. Median Time to First Dementia-Related NH Placement Months Maximum donepezil exposure (n=310) 66.1 Limited donepezil exposure (n=113) 44.7 21.4 month delay 010203040506070 Persistent treatment with donepezil may have delayed time to 1st dementia-related NH placement by nearly 2 years

15 Benefits of Treating Moderate to Severe AD Domains of Efficacy Benefits of Treating Moderate to Severe AD Domains of Efficacy Behavior Function Cognition Physical and Psycho-social Well-being Reduced caregiver burden Pharmaco- economic benefit Reduced Behaviors CMS GOAL

16 Restore functional capacity, and slow decline Reduce severity of behaviors Reduce and forestall new use of psychotropic agents Realize pharmacoeconomic benefits from Reduction in behaviors and behavior medications Reduction in care giver burden Reduction in acuity of co-morbidities Goals for Moderately Severe to Severe Patients Psychiatric Medicine Consensus Reports Alzheimers Disease: Risk Stratification, Patient Evaluation, and Outcome-Effective Pharmacologic Therapy, Year 2004 Clinical Update

17 Donepezil Effects on ADLs & Caregiver Burden Feldman et al, JAGS 2003 Community dwelling and ALF AD patients N=290, MMSE range 5-17 Measurements by Disability Assessment for Dementia Scale (DAD) Modified Instrumental Activities of Daily Living Scale (IADL+) Modified Physical Self Maintenance Scale (PSMS+) Feldman H, et al. J Am Geriatr Soc. 2003;51:737-744.

18 Caregivers Spent Less Time Assisting Patients With ADLs Feldman H, et al. Efficacy of donepezil on maintenance of activities of daily living in patients with moderate to severe Alzheimers disease and the effect on caregiver burden. J Am Geriatr Soc. 2003;51:737-744.

19 Behaviors Are Costly The costs of behavioral management for AD patients is significant The costs of behavioral management for AD patients is significant Kleinman, et al l l Behaviors due to dementia, psychosis, agitation/aggression and depression cost $5.23 per occurance in intervention and documentation l l Based on staff mix, frequency, and median US wages (2001), behavioral management costs between $75 and $344 PER PATIENT PER MONTH Beeri, et al l l 30% of the total annual cost of caring for an AD patient is invested in behavioral management Kleinman, et al: Consult Pharm 2002; 17:497-507 Beeri, et al: Int J Geriatri Psychiatry 2002; 17:403-408

20 Rivastigmine Effects on Behavior Edwards, et al Nursing Home AD patients 26 week open label prospective study, with 26 week open label extension N=173, MMSE range 6-15 Neuropsychiatric Inventory, Nursing Home Version (NPI-NH) 85% of patients receiving therapeutic doses at study end (6-12mg/day) Edwards, et al: Clin Drug Invest 2005; 125(8) 507-515

21 Rivastigmine Effects on Behavior Baseline Edwards, et al: Clin Drug Invest 2005; 125(8) 507-515

22 Rivastigmine Effects on Behavior 52 Week Endpoint Edwards, et al: Clin Drug Invest 2005; 125(8) 507-515 n=43 n=36 n=62 n=55 n=36 n=72

23 Rivastigmine Effects on Behavior 15% of patients increased their dose of any psychotropic 11% of those on an antipsychotic 15% of those on an antidepressant 3% of those on an anxiolytic 8% of those on a hypnotic 2% of patients receiving no psychotropic started one

24 Rivastigmine & Behavior: Psychotropic Medication Use in Nursing Home AD Patients Edwards KR, et al. In: Proceedings of the US Psych and Mental Health Congress. 1999.

25 Galantamine in Advanced Disease Blesa, et al: Post hoc pooled data study of 4 phase III registration trials 6 month placebo-controlled double blind randomized studies with 6 month open label extensions: consistent study design validates pooling Group 1 (N=72) MMSE<12, galantamine 24mg/day vs placebo. Group 2 (N=165) ADAS-Cog>30, galantamine 24mg/day vs placebo) Blesa, R., et al: Dement Geriatr Cogn Disorder 2003; 15:79-87

26 Galantamine in Advanced Disease Blesa, R., et al: Dement Geriatr Cogn Disorder 2003; 15:79-87

27 Galantamine in Advanced Disease Blesa, R., et al: Dement Geriatr Cogn Disorder 2003; 15:79-87

28 Donepezil in Advanced Disease Winblad, et al: Swedish nursing home AD patients(DSM-IV) 26 week, randomized, double-blind, placebo controlled study N=194, MMSE=1-10 Severe Impairment Battery (SIB) Alzheimers Disease Cooperative Study –Activities of Daily Living-severe (ADCS-ADL-sev) Randomized to 5mg/daily x 4 weeks then option to increase to 10mg/daily, vs placebo Mean donepezil dose was 8.2mg/day; 91% reached 10mg/day Winblad, et al: Donepezil in Patients with Severe Alzheimers Disease: doubleblind, parallelt-group, placebo-controlled study. The Lancet 2006:367:1057-1065

29 Winblad, et al: Donepezil group improved on SIB l l Mean improvement of 5.7 (95% CI 1.5-9.8) p=0.008 l l Placebo group mean decline of 1.8 Donepezil group declined less on ADCS-ADL-severe l l Mean of decline of 1.7 (95% CI 0.2-3.2) p=0.03 l l Placebo group mean decline of 2.9 Winblad, et al: Donepezil in Patients with Severe Alzheimers Disease: doubleblind, parallelt-group, placebo-controlled study. The Lancet 2006:367:1057-1065 Donepezil in Advanced Disease

30 Memantine in Moderate to Severe Alzheimers Disease Memantine in Moderate to Severe Alzheimers Disease Reisberg B et al. N Engl J Med. 2003;348:1333-1341 Reisberg B et al. N Engl J Med. 2003;348:1333-1341

31 Study Design Design Phase 3, multicenter (32; US), randomized, double- blind, placebo-controlled study Phase 3, multicenter (32; US), randomized, double- blind, placebo-controlled studyPopulation 252 outpatients with moderate to severe AD (MMSE range, 3-14) 252 outpatients with moderate to severe AD (MMSE range, 3-14)Treatment Memantine 20 mg/day (10 mg bid) 4-week titration (5 10 15 20 mg) Memantine 20 mg/day (10 mg bid) 4-week titration (5 10 15 20 mg)Duration 28 weeks + 24-week open-label extension* 28 weeks + 24-week open-label extension* Reisberg B et al. N Engl J Med. 2003;348:133301341 Ferris S et al. Presented at the 16 th Annual Meeting of the American Association for Geriatric Psychiatry; March 1-4, 2003; Honolulu, HI Reisberg B et al. N Engl J Med. 2003;348:133301341 Ferris S et al. Presented at the 16 th Annual Meeting of the American Association for Geriatric Psychiatry; March 1-4, 2003; Honolulu, HI

32 Outcome Measures Primary Efficacy Variables GlobalCIBC-Plus GlobalCIBC-Plus FunctionalADCS-ADL 19 FunctionalADCS-ADL 19inventory (modified 19 item) Reisberg B et al. N Engl J Med. 2003;348:133301341

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34 Memantine/Donepezil Dual Therapy Is Superior to Placebo/Donepezil Therapy for Treatment of Moderate to Severe Alzheimers Disease Tariot P et al. J Am Geriatr Soc. 2003;51(S4):S225-S226 Tariot P et al. J Am Geriatr Soc. 2003;51(S4):S225-S226

35 Study Design Randomized, double-blind, placebo-controlled, parallel group study Randomized, double-blind, placebo-controlled, parallel group study 1-2 to 2-week single-blind placebo lead-in 1-2 to 2-week single-blind placebo lead-in 24-week double-blind treatment 24-week double-blind treatment Memantine 20 mg/day (10 mg bid), titrated over a 4-week period, or placebo, combined with stable doses of donepezil Memantine 20 mg/day (10 mg bid), titrated over a 4-week period, or placebo, combined with stable doses of donepezil 37 investigator sites in the United States 37 investigator sites in the United States Tariot P et al. J Am Geriatr Soc. 2003;51(S4):S225-S226

36 Entrance Criteria Diagnosis of probable AD consistent with NINCDS-ADRDA criteria Diagnosis of probable AD consistent with NINCDS-ADRDA criteria MRI or CT scan consistent with probable AD MRI or CT scan consistent with probable AD MMSE scores of 5 to 14 at screening and baseline MMSE scores of 5 to 14 at screening and baseline Donepezil monotherapy for >6 months prior to entrance and at stable doses (5 to 10 mg/day) for the 3 months preceding and throughout the study period Donepezil monotherapy for >6 months prior to entrance and at stable doses (5 to 10 mg/day) for the 3 months preceding and throughout the study period Tariot P et al. J Am Geriatr Soc. 2003;51(S4):S225-S226

37 Functional Efficacy Assessment Alzheimers Disease Cooperative Study- Activities of Daily Living modified 19 - item inventory (ADCS-ADL 19 ) Alzheimers Disease Cooperative Study- Activities of Daily Living modified 19 - item inventory (ADCS-ADL 19 ) Tariot P et al. J Am Geriatr Soc. 2003;51(S4):S225-S226

38 Secondary Functional Efficacy Assessments Global Global - Clinicians Interview-Based Impression of Change plus caregiver input (CIBIC- Plus) Function Function -Behavioral Rating Scale for Geriatric Patientscare dependency subscale (BGP-Care) Tariot P et al. J Am Geriatr Soc. 2003;51(S4):S225-S226

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40 Treatment for early to moderate stage ALF AD patients focuses on improving and maintaining cognition, maintaining ADLs, and slowing emergence of behaviors. Cost savings are associated with delayed nursing home admission. Treatment for early to moderate stage ALF AD patients focuses on improving and maintaining cognition, maintaining ADLs, and slowing emergence of behaviors. Cost savings are associated with delayed nursing home admission. Treatment for moderate to severe stage NF patients focuses on maintaining ADLs and slowing functional decline, and controlling behaviors. Cost savings are associated with reduced staff time, reduced psychotropic use. Treatment for moderate to severe stage NF patients focuses on maintaining ADLs and slowing functional decline, and controlling behaviors. Cost savings are associated with reduced staff time, reduced psychotropic use. Moderate and Severe stage AD patients in all setting benefit from persistent treatment with cholinesterase inhibitors, and/or NMDA receptor antagonists Moderate and Severe stage AD patients in all setting benefit from persistent treatment with cholinesterase inhibitors, and/or NMDA receptor antagonists Benefits are both clinically significant for patients, and economically significant for care givers and healthcare systems Benefits are both clinically significant for patients, and economically significant for care givers and healthcare systems Summary


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