Clinical Experiences and Methodologic Challenges in Conducting Clinical Trials on the Behavioral Disturbances of Dementia

With a world population increasing in size and age, the number of elderly people with behavioral distrubances in dementia (BDD) is becoming an increasing problem. The burden of caring for someone with BDD may be so great that it leads to premature institutionalization of the patient. Few clinical trials have focused on noncognitive behavioral symptoms in this group of elderly patients, and little is known about the efficacy of drugs against these symptoms. The pharmaceutical companies have recently begun to assess different medications, but clinical trials in the elderly present a variety of problems not encountered in other patient populations. This article describes how the administration, initiation, logistics, finances, and methodology of such trials must be carefully assessed. Consideration of these factors together with improved definitions of behavioral symptoms and the advances in medication in this area should lead to an improvement in the treatment and management of behavioral disorders in the elderly.

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Meta-Analysis of Controlled Pharmacologic Trials

International Psychogeriatrics ◽

10.1017/s1041610297003669 ◽

1997 ◽

Vol 8 (S3) ◽

pp. 375-379 ◽

Cited By ~ 15

Author(s):

Lon S. Schneider

Keyword(s):

Valproic Acid ◽

Clinical Trials ◽

Elderly Patients ◽

Psychotropic Drugs ◽

Meta Analysis ◽

Behavioral Symptoms ◽

Relative Efficacy ◽

Behavioral Disturbances ◽

Drug Classes ◽

Adrenergic Blockers

Both pharmacologic and nonpharmacologic methods can be used to treat behavioral disturbances of dementia. Many drugs and drug classes have been advocated as having putative efficacy in treating nonspecific behavioral symptoms; the list includes neuroleptics, anxiolytics, antidepressants (e.g., trazodone), anticonvulsants (e.g., carbamazepine and valproic acid), lithium, β-adrenergic blockers, selegiline, and buspirone. Neuroleptics are among the most commonly prescribed psychotropic drugs for behavioral symptoms and have been described as being “modestly effective” in controlling agitation, both in patients with dementia and in elderly patients in general. To examine the relative efficacy of neuroleptics in treating behavioral disturbances of dementia, the author and colleagues performed a meta-analysis of clinical trials published in the literature from 1954 to 1989.

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A large series of extracorporeal shockwave lithotripsy in the very elderly

Therapeutic Advances in Urology ◽

10.1177/1756287219870412 ◽

2019 ◽

Vol 11 ◽

pp. 175628721987041

Author(s):

Guilherme Braga Lamacchia ◽

Fernando Korkes ◽

Willy Baccaglini ◽

Luiz Gustavo Miolaro de Mello ◽

Marcelo Szwarc ◽

...

Keyword(s):

Elderly Patients ◽

Elderly People ◽

Urinary Calculi ◽

The Elderly ◽

Extracorporeal Shockwave Lithotripsy ◽

Urinary Stones ◽

Shockwave Lithotripsy ◽

World Population ◽

Very Elderly ◽

Extracorporeal Shockwave

Background: The incidence of urinary lithiasis has been increasing in recent decades at all ages, including the elderly. In parallel, the world population is aging and there is a paucity of data on treatment of urinary stones in very elderly people. Our main objective was to evaluate the effects of extracorporeal shockwave lithotripsy (ESWL) in patients older than 75 years, and the characteristics of this population. Complications and mortality rates after this procedure in octogenarians were also described. Methods: We retrospectively evaluated very elderly patients who underwent ESWL at our institution from 1998 to 2015, through chart review, telephone interviews, and consultation with the municipal mortality information program. Measured outcomes included demographic and clinical data, ESWL characteristics and complications, interval between ESWL and death, and cause of death. Results: Demographic and treatment characteristics were similar between very elderly and younger patients who underwent ESWL during the same period. No severe complications occurred among older patients. Octogenarians treated in our cohort had a significant life expectancy when ESWL procedures were performed. Even though 38.9% of the patients passed away during the studied period, mortality occurred on average 4.38 years after the ESWL session. Conclusions: In conclusion, ESWL has been used by urologists as a first-line treatment for uncomplicated urinary calculi in very elderly patients. Despite changes associated with aging, and the high prevalence of comorbidities, this procedure seems to be safe and well tolerated in elderly people.

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Safety of High-Dose Dabigatran in Elderly and Younger Patients with a Low Bleeding Risk: A Prospective Observational Study

Cardiology ◽

10.1159/000516368 ◽

2021 ◽

pp. 1-5

Author(s):

Aharon Erez ◽

Gregory Golovchiner ◽

Robert Klempfner ◽

Ehud Kadmon ◽

Gustavo Ruben Goldenberg ◽

...

Keyword(s):

Observational Study ◽

Elderly Patients ◽

Prospective Observational Study ◽

Bleeding Risk ◽

The Elderly ◽

High Dose ◽

World Population ◽

Younger Patients ◽

End Point

Introduction: In patients with atrial fibrillation (AF) at risk for stroke, dabigatran 150 mg twice a day (DE150) is superior to warfarin for stroke prevention. However, there is paucity of data with respect to bleeding risk at this dose in elderly patients (≥75 years). We aimed to evaluate the safety of DE150 in comparison to warfarin in a real-world population with AF and low bleeding risk (HAS-BLED score ≤2). Methods: In this prospective observational study, 754 consecutive patients with AF and HAS-BLED score ≤2 were included. We compared outcome of elderly patients (age ≥75 tears) to younger patients (age <75 years). The primary end point was the combined incidence of all-cause mortality, stroke, systemic emboli, and major bleeding event during a mean follow-up of 1 year. Results: There were 230 (30%) elderly patients, 151 patients were treated with warfarin, and 79 were treated with DE150. Fifty-two patients experienced the primary endpoint during the 1-year follow-up. Among the elderly, at 1-year of follow-up, the cumulative event rate of the combined endpoint in the DE150 and warfarin was 8.9 and 15.9% respectively (p = 0.14). After adjustment for age and gender, patients who were treated with DE150 had a nonsignificant difference in the risk for the combined end point as patients treated with warfarin both among the elderly and among the younger population (HR 0.58, 95% C.I = 0.25–1.39 and HR = 1.12, 95% C.I 0.62–2.00, respectively [p for age-group-by-treatment interaction = 0.83). Conclusions: Our results suggest that Dabigatran 150 mg twice a day can be safely used among elderly AF patients with low bleeding risk.

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Old hypertensive patient: a hard challenge

Italian Journal of Medicine ◽

10.4081/itjm.2009.109 ◽

2013 ◽

pp. 109-112

Author(s):

Giuseppe Rossetti ◽

Diana Solari ◽

Maria Laura Rainoldi ◽

Stefano Carugo

Keyword(s):

Blood Pressure ◽

Cardiovascular Risk ◽

Elderly People ◽

Diastolic Pressure ◽

Beta Blockers ◽

The Elderly ◽

Pressure Control ◽

World Population ◽

Continuous Increase ◽

Hypertensive Therapy

BACKGROUND High blood pressure is one of the most important cardiovascular risk factor and its incidence is continuously increasing: on 2025 1/3 of adult world population will suffer of it. Moreover, the therapy of elderly hypertension sufferer patient is still growing up in importance for the continuous increase of world population average life. With ageing, the cardiovascular system suffers neurohormonal and haemodinamic modifications which determine the onset of isolate systolic hypertension, which is characteristic of the elderly. This pathology results linked to a higher cardiovascular risk. AIM OF THE STUDY This review aims to analyze and evaluate present and future therapeutic opportunities about anti-hypertensive therapy in elderly people. DISCUSSION AND CONCLUSIONS Also in elderly people systolic blood pressure values must be lower than 150 mmHg, but it’s also important to maintain diastolic pressure not under 70 mmHg, to avoid phenomenons of cerebral and coronary hypo-perfusion (J curve). The benefits of an effective anti-hypertensive therapy are achieved thanks to both blood pressure lowering “per se” and to the decrease of cardiovascular mortality and morbility. Blood pressure control in the elderly is a hard challenge for the low compliance to the therapy, for the importance of the comorbidity and for the supplementary risk factors. ESH-ESC 2007 guidelines recommend for elderly highblood pressure sufferer patient the use first of all of calcium-antagonists and thiazides diuretics, and for second line ACE-inhibitors, ARB and beta-blockers. In several patients combinations of two or more drugs are necessary to obtain pressure control.

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Inclusive Design: An Approach to Adapt Homes for the Elderly

10.53350/pjmhs211551599 ◽

2021 ◽

Vol 15 (5) ◽

pp. 1599-1603

Author(s):

Hossein Fallah ◽

Jalil Nazari ◽

Alireza Choobineh ◽

Mohammad Ali Morowatisharifabad ◽

Mohamad Asghari Jafarabadi

Keyword(s):

Older People ◽

Elderly People ◽

The Elderly ◽

Inclusive Design ◽

World Population ◽

Disabled People ◽

Homes For The Elderly ◽

The World ◽

The Disabled ◽

Current Design

The aging trend of the world population has increased the number of elderly people. Older people prefer to spend most of their time at home. The problem is that today's homes are often unsuitable for the elderly and the disabled. Thus, problems of the current design approaches, which are based on percentiles as well as the tendency to involve the elderly and disabled people in society, have put the concept of inclusive design into consideration. Application of new design approaches, such as inclusive design allows designers to design products and services to meet the needs of a larger group of users regardless of their age and ability. Given the rapid aging of the world population, more research is needed to design specific products and environments for elderly people. Keywords: Home design, Aging, Ergonomics, Adaptation

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Treatment with CPAP in Elderly Patients with Obstructive Sleep Apnoea

Journal of Clinical Medicine ◽

10.3390/jcm9020546 ◽

2020 ◽

Vol 9 (2) ◽

pp. 546 ◽

Cited By ~ 1

Author(s):

Tomas Posadas ◽

Grace Oscullo ◽

Enrique Zaldívar ◽

Alberto Garcia-Ortega ◽

José Daniel Gómez-Olivas ◽

...

Keyword(s):

Clinical Trials ◽

Elderly Patients ◽

Obstructive Sleep Apnoea ◽

The Elderly ◽

Sleep Apnoea ◽

Age Group ◽

Obstructive Sleep ◽

Receive Treatment ◽

Therapeutic Tools

The population pyramid is changing as a result of the ever-increasing life expectancy, which makes it crucial to acquire an in-depth understanding of the diseases that most often affect the elderly. Obstructive sleep apnoea (OSA) affects 15%–20% of the population aged over 65 years. Despite this prevalence, there have been very few specific studies on the management of OSA in this age group, even though over 60% of the patients aged over 65-70 years who attend sleep units with suspicion of OSA receive treatment with continuous positive airway pressure (CPAP), on the basis of an extrapolation of the positive results achieved by CPAP in clinical trials involving middle-aged males. However, the latter’s form of presentation, evolution and, probably, prognosis comparing with OSA are not the same as those of elderly patients. Recent clinical trials performed on an exclusive series of elderly patients have shed light on the possible role of CPAP treatment in elderly patients with OSA, but there are still many questions that need to be answered. The physiological increase in the number of sleep-related disorders with the passing of years, and the lack of validated diagnostic and therapeutic tools for this age group are probably the greatest obstacles to define, diagnose and treat OSA in the elderly.

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Cisplatin-induced renal toxicity in elderly people

Therapeutic Advances in Medical Oncology ◽

10.1177/1758835920923430 ◽

2020 ◽

Vol 12 ◽

pp. 175883592092343 ◽

Cited By ~ 5

Author(s):

ZhiYu Duan ◽

GuangYan Cai ◽

JiJun Li ◽

XiangMei Chen

Keyword(s):

Elderly Patients ◽

Elderly People ◽

Renal Toxicity ◽

Enzyme Inhibitor ◽

Interstitial Fibrosis ◽

Angiotensin Receptor Blockers ◽

Young Patients ◽

Kidney Injury ◽

The Elderly ◽

Tubular Atrophy

Despite available prevention and treatment measures, such as hydration, diuresis, magnesium supplementation, and amifostine, renal toxicity is still one of the major dose-limiting side effects of cisplatin. The aim of this review is to discuss the issue of cisplatin-induced nephrotoxicity in the elderly. Compared with young patients, the incidences of cisplatin-induced nephrotoxicity and acute kidney injury (AKI) in elderly patients are significantly increased, and survival time may be decreased. Following cisplatin treatment of elderly patients, tubulointerstitial injuries will be significantly aggravated based on their original age, both for acute injuries due to cell necrosis and exfoliation and chronic injuries due to interstitial fibrosis, tubular atrophy, and dilatation. The high incidence of cisplatin-induced nephrotoxicity in elderly patients may be associated with renal hypoperfusion; increased comorbidities, such as chronic kidney disease (CKD), cardiovascular disease, and diabetes mellitus; increased use of combined drugs [especially non-steroidal anti-inflammatory drugs, angiotensin-converting enzyme inhibitor and angiotensin receptor blockers (ACEI/ARB), and antibiotics]; decreased clearance of cisplatin; and high plasma ultrafilterable cisplatin. Considering hemodynamic stability and water balance, short duration and low volume hydration may be more suitable for treating elderly people. With the increasing popularity of low-dose daily/weekly regimens, we do not recommend routine diuretic treatment for elderly patients. We recommend using a less nephrotoxic platinum if large doses of cisplatin (100mg/m2) are needed.

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Systemic Therapy for Elderly Patients with Gastrointestinal Cancer

Clinical Medicine Insights Oncology ◽

10.4137/cmo.s6983 ◽

2011 ◽

Vol 5 ◽

pp. CMO.S6983 ◽

Cited By ~ 1

Author(s):

Joleen M. Hubbard ◽

Axel Grothey ◽

Daniel J. Sargent

Keyword(s):

Clinical Trials ◽

Elderly Patients ◽

Systemic Therapy ◽

Survival Benefit ◽

Older Patients ◽

The Elderly ◽

Age Group ◽

Gastrointestinal Cancers ◽

Younger Patients ◽

Multiple Trials

The majority of patients with gastrointestinal cancers are over the age of 65. This age group comprises the minority of the patients enrolled in clinical trials, and it is unknown whether older patients achieve similar results as younger patients in terms of survival benefit and tolerability. In addition, there are few studies specifically designed for patients over 65 years. Subset analyses of individual trials and studies using pooled patient data from multiple trials provide some understanding on outcomes in older patients with gastrointestinal cancers. This article reviews the evidence on chemotherapeutic regimens in the elderly with colorectal, pancreatic, and gastroesophageal cancers, and discusses a practical approach to provide the best outcomes for older patients.

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Valproic Acid-Induced Myoclonus in a Demented Patient: A Case Report

Case Reports in Medicine ◽

10.1155/2009/392091 ◽

2009 ◽

Vol 2009 ◽

pp. 1-3 ◽

Cited By ~ 3

Author(s):

Tina M. Gardner ◽

Rehan Aziz ◽

Sunanda Muralee ◽

Rajesh R. Tampi

Keyword(s):

Valproic Acid ◽

Case Report ◽

Elderly Patients ◽

Psychiatric Disorders ◽

Early Onset ◽

The Elderly ◽

Demented Patient ◽

Behavioral Disturbances ◽

Neuropsychiatric Complications

Valproic acid and its derivatives are now commonly used to treat various psychiatric disorders in the elderly. Data indicates that the elderly patients are more susceptible to developing neuropsychiatric complications when treated with these medications. In this report, we describe the case of a 66-year-old woman with early-onset, Alzheimer's type dementia, who developed myoclonus when treated with a valproic acid preparation for behavioral disturbances associated with the dementia.

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Inappropriate prescribing in hospitalized elderly patients

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20171077 ◽

2017 ◽

Vol 6 (4) ◽

pp. 701

Author(s):

Lina K. Massoud ◽

Hala Z. AlAgha ◽

Mahmoud H. Taleb

Keyword(s):

Elderly Patients ◽

Elderly People ◽

Inappropriate Prescribing ◽

The Elderly ◽

Potentially Inappropriate Medications ◽

Hospitalized Elderly ◽

Different Types ◽

Elderly Inpatients ◽

Hospitalized Elderly Patients ◽

Inappropriate Medications

Inappropriate prescribing (IP) is a major healthcare problem in elderly patients. The risk of this problem increases during hospitalization. This is due to increase morbidity and thus increases the use of medications by the inpatients. This study will clarify the problem of IP for elderly people during hospitalization and will identify the different types of it. It also will highlight some tools that are used to assess the different types of IP and the prevalence of it in elderly patients during hospitalization. Finally, the study will address the consequences of IP in the elderly inpatients and the risks associated with the use of some potentially inappropriate medications (PIMs) in the elderly.

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