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Agitation in Alzheimer's Disease Lessons Learned: Agitation in Alzheimer’s Disease International Society for Clinical Trials in Medicine 9/2/17 Paris, France Paul B. Rosenberg, M.D. Associate Professor of Psychiatry and Behavioral Sciences Johns Hopkins University School of Medicine Disclosures • Research support – National Institute on Aging, Alzheimer’s Association, Lilly, Functional Neuromodulation (FNMI), Lilly, Abbvie • Consulting/advisory boards – Lundbeck, Abbvie, GLG, Leerink, Otsuka, Avanir, Astellas • Travel – Avanir, Otsuka • No stock, royalties, patents Agenda Agitation in Alzheimer’s Disease (AD) • Nosology • Outcome measures • Current state of treatments • Recent trials results • Study design • Potential neurobiological mechanisms • Distinguishing improvement in agitation from improvement in cognition (“pseudospecificity”) Nosology Agitation: core phenotype • Emotional agitation: distress, upheaval, anger, tension, anxiety, worry, inability to relax Too many adjectives! • Lability: rapidNeed changes to reduce in heterogeneity mood, irritability, unexpectedSimilar outbursts, issue tooverreacting, defining psychosis catastrophizing • Psychomotorand major agitation depression: pacing, rocking, restless, gesticulating, pointing fingers, • Verbal aggression: yelling, excessively loud voice, screaming, use of profanity, threats, "in your face" • Physical aggression: grabbing, shoving, pushing, resisting, hitting, kicking, getting in the way Abridged criteria from International Psychogeriatric Association (2015) A. Cognitive impairment or dementia syndrome B. Patient exhibits at least one of the following behaviors which are associated with observed or inferred evidence of emotional distress sustained or persistent for a minimum of two weeks’ duration and represents a change from the person’s usual behavior.Phenotypically recognizable – Excessive motorReasonably activity homogenous – Verbal aggressionExcludes “minor” agitation – Physical aggression C. Disability greater than cognitive impairment alone – interpersonal relationships – other aspects of social functioning – ability to perform or participate in daily living activities D. not attributable solely to another psychiatric disorder, medical condition, or the physiological effects of a substance Cummings et al, International Psychogeriatrics 2015 NPI:Outcome widely used Measures for Agitation in AD informant report Domains not free-standing CMAI: agitation-specific very detailed description of agitation Broadinformant spectrum report Agitation-focused • Neuropsychiatricsubscales not widely used •(verbalCohen aggression,-Mansfield Inventoryphysical (NPI) aggression, (12 etc.)Agitation Inventory domains) NPI-C: NPI “broadened and deepened”(CMAI) • NeuropsychiatricAbout twice as many questions Inventory-Clinician • NPI Clinician makes judgment based on informant Version (NPI-C) (16 Agitation/Aggression domains)report and interview• ofNPI patient-C Agitation and Domains are free-standing • Neuropbehavioral Aggression (separate RatingSplits Scale up Agitation(NBRS) and Aggressiondomains) Most studies look at both Agitation and Aggression • Behave-AD and their sum Steinberg & Lyketsos APA Handbook of Psychiatric Measures, 2007 NPI-C (Clinician Rated) Improved NPI • Broad spectrum: NPI with clinician rating • Narrow spectrum: target specific areas • Improved range for early (MCI) and severe disease • Translated into: Spanish, French, Portuguese, Italian, Greek • High inter-rater reliability: ICC= 0.78-0.98 • Strong convergent validity for – Depression (CSDD), Psychosis (BPRS), Apathy (AES), Agitation (CMAI) de Medeiros et al, Int Psychogeriatrics, 2010 Current treatments Disappointing and/or risky • Non-pharmacologic: very few data – Custom Activity Program RCT at Hopkins • Pharmacologic: none approved in US – FDA-approved AD medications (cholinesterase inhibitors; memantine): weak benefit – Antipsychotics: widely used, efficacy dubious, black box warningfor mortality – Anticonvulsants: ineffective risky – Benzodiazepines: ineffective, risky – Antidepressants: many ineffective • Except new data on SSRIs (Kostas’ talk) CitAD (N=186): Response rate citalopram 40% vs. placebo 26% Porsteinsson et al, JAMA 2014 Placebo response (28%) by week 3 Citalopram (40%) response 9+ weeks Weintraub et al, Am J Geriatric Psych 2015 CitAD: adverse events • Anorexia, diarrhea, fever more common on citalopram (p<0.05) • MMSE decline of 1pt on citalopram (P<0.05) • QTc prolongation on citalopram Porsteinsson et al, JAMA 2014 Conclusion: try s-citalopram (escitalopram, Lexapro) QTc prolongation associated with r- Clinical response associated with s- citalopram levels citalopram levels Response probability MMSE decline associated with r-citalopram levels J Clinical Pharmacology, in press Escitalopram (S-CitAD) N=589 R01AG052510; PI: Lyketsos 5HT2 antagonists • Pure 5HT2 antagonists (no dopaminergic antagonism) • Pimavanserin=FDA approved for psychosis in Parkinson’s disease Cummings et al., 2014 • Well tolerated in PD with no measurable increase in EPS and only modest sedation • Promising results in 12-week Phase 2 AD agitation trial (U.K., N=181) – At six weeks Participants on PIM had 3.76 point decrease in NPI- NH Psychosis (from baseline of ~ 10) vs. 1.93 points on placebo (p=.045) – Results not statistically significant at 12 weeks though similar – No detriment in cognition • Pimavanserin (Acadia) and ITI-007 (Intracellular Therapeutics) in phase 3 trials for agitation in AD • Nelotanserin (inverse 5HT2 agonist, Axovant) not tested in agitation in AD THC Rationale Prior studies • Active ingredient of marijuana • Case series (N=40) at McLean • CB1 and CB2 cannabinoid Hospital Woodward et al., 2013 receptor agonist – Dronabinol used for agitation in AD • CB1 = likely associated with – Mean dose ~ 7 mg daily anxiety – Notable reduction in Pittsburgh • CB2 = likely anti-inflammatory Agitation Scale and subdomains effect – AEs: sedation (N=7), delirium • THC = dronabinol, schedule III (N=4) FDA-approved for anorexia • RCT of THC in Netherlands Van den Elsen, • Being more widely used for 2015 – N=50, dose = 4.5 mg daily, behavioral symptoms in AD duration = 3 weeks • Surprisingly benign – Null effect – Probably underdosed THC-AD Paul B. Rosenberg, M.D (Johns Hopkins) Brent Forester, M.D. (McLean/Harvard) Study experience to date: Krista Lanctot and Nathan Herrmann 7 patients randomized (Sunnybrook, Toronto, CA) No notable AEs 6-week crossover RCT of nabilone vs. High acuity placebo (target dose 2 mg) liberalizing prn lorazepam from .5 Cohen-Mansfield Agitation Inventory = mg daily to .75 mg daily and 1o outcome allowing intramuscular as well as oral use Still, a hard study to do! One patient had difficulty swallowing overencapsulated medication 4 years to go Prazosin • Postsynaptic α1 noradrenergic • 8-week RCT of prazosin for receptors involved with PTSD agitation in 22 AD patients – Although efficacy in PTSD is • Mean dose 5.7 mg daily questionable • Mean NPI decreased from 49 to • Prazosin is an α1 antagonist 30 on prazosin – FDA approved for – vs. 43 to 41 on placebo hypertension and BPH – Similar results for BPRS • Prazosin improves sleep and and CGI-C reduces nightmares in PTSD • Minimal AEs (including no Raskind et al., 2007 hypotension!) • Why not AD? which frequently involves disrupted sleep and • PEACE-AD = multi-site trial probable circadian rhythm through ADCS (UCSD) (PIs disturbances Murray Raskind and Elaine Peskind) Study design issues • Duration • Adaptive trial designs – Most studies 12 weeks or less – Accounts for sizable placebo – CitAD: placebo response effect maxed out at 3 weeks while – Need to recruit larger N benefit continued to 9 weeks – For example, S-CitAD will use – Suggests 9 weeks as minimum 3-week psychosocial • Dementia care support intervention run-in – Most patients and families get • Concomitant medications little support for dementia care – Acetylcholinesterase inhibitors and in the community memantine mostly included – Psychosocial intervention • only modest effect on agitation, at best (DIADS, ADMET, CiTAD, S- – Antidepressants and antipsychotics CiTAD) • varied inclusion/exclusion • Enhanced usual care – Trazodone usually allowed for sleep • Ethically important – Benzodiazepines controversial • High retention • We have been using lorazepam up to 0.5 mg daily as prn Study design issues (2) • Agitation inclusion • Cognition/dementia severity – Most studies have converged – Most studies use MMSE on NPI-Agitation Frequency X minimum of 10 or 5 Severity of 4 or greater – Below 10, I believe MMSE – Frequent occurrence + largely reflects language skills moderate severity OR Often – THC-AD has no minimum occurrence + marked severity • Adverse events • Target population – Sedation – Citalopram more effective in – Falls younger outpatients with less severe agitation – Cognitive worsening – Essentially ineffective in nursing – QTc prolongation home patients • Topic of great regulatory – THC-AD targeting inpatients, interest most with severe agitation and • I am skeptical that it is truly severe dementia severity associated with cardiac AEs Active Agitation-AD drug trials clinicaltrials.gov (August 2017) • 10 standard RCTs, 2 crossover • 3-12 weeks (the 3 week trial is inpatient) • Mostly outpatient settings (1 inpatient, 1 CCRC) • Agitation inclusions vary, either IPA criteria or NPI Agitation > 4 • CMAI primary in 9; NPI-C or NPI Agitation in 3 • MMSE minimum varies from 0 to 6 • Drugs from all classes mentioned – 5HT2 antagonists (2) (pimavanserin, ITI-007) – Deuterated DMQ (AVP-386, Avanir)
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