[P‐205]: Safety and efficacy of donepezil in a 12‐week, open‐label trial in African Americans with mild to moderate Alzheimer's disease

Griffith, Patrick; Lichtenberg, Peter A.; Goldman, Robert; Burger, Lynn; Lato, June; Payne-Parrish, Jennifer; Richardson, Sharon

doi:10.1016/j.jalz.2005.06.263

Cited by 9 publications

(13 citation statements)

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“…Donepezil was well tolerated and significantly improved global cognition, memory retrieval and attention/concentration from baseline. All of these results are consistent with those reported for donepezil in studies of predominantly non-Hispanic white subjects14–16 and those of a study in African Americans with AD (the Treating African-American Alzheimer’s Patients, or TAAAP, study) 27. In addition, there was also a numeric improvement in 9 of 12 NPI domains, with that for apathy/indifference achieving statistical significance.…”

Section: Discussionsupporting

confidence: 87%

“…However, the overwhelming evidence from double-blind, placebo-controlled studies is that practice effects contribute minimally to the cognitive improvement seen with donepezil treatment. Although this was an open-label design with approximately 100 subjects examined, the efficacy and safety results were consistent with those that have been reported for donepezil in the general population and in a similarly designed study of African Americans (TAAAP) 14–16,27. These results also support earlier findings of a greater prevalence of AD at earlier ages in Hispanics 7–10.…”

Section: Discussionsupporting

confidence: 86%

“…The results of this study are consistent with these epidemiologic observations: 35% of Hispanic subjects in this study were <65 years of age. The mean age of Hispanics with AD in the present study is 6–10 years less than that of a predominantly white study population,28 and 8 years less than a study population of African Americans with AD 27. In a retrospective database analysis carried out at 5 AD centers, the mean age at symptom onset for 366 Hispanic patients with a clinical diagnosis of AD was 68.8 years, compared with 73.5 years for 2,823 white patients 10.…”

Section: Discussioncontrasting

confidence: 65%

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Effectiveness and Safety of Donepezil in Hispanic Patients with Alzheimer’s Disease: A 12-Week Open-Label Study

López

Mackell

Sun

et al. 2008

Journal of the National Medical Association

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Background Hispanics represent 10% of the U.S. population and are the fastest growing group. Studies show a higher prevalence and incidence of Alzheimer’s disease (AD) in Hispanics than in the non-Hispanic white population, with an earlier age of onset. Among the currently estimated 200,000 Hispanics with AD, a significant number remain undiagnosed and untreated, and Hispanic participation in AD clinical trials has been historically low. This study evaluated the efficacy and safety of donepezil hydrochloride (donepezil) in Hispanics with mild-to-moderate AD. Methods In this multicenter, open-label, 12-week study conducted in the United States, subjects were Hispanic men or women aged ≥50 years with a diagnosis of mild-to-moderate AD (DSMV-IV and NINCDS/ADRDA criteria), with Mini-Mental State Examination (MMSE) scores of 10–26 (inclusive) at screening. Subjects were treated with donepezil 5 mg/day for 6 weeks followed by 10 mg/day for 6 weeks. Clinical evaluation was performed at baseline, week 6 and week 12. Cognitive improvement was measured using the MMSE, Fuld Object Memory Evaluation (FOME) and Symbol Digit Modality Test (SDMT). Behavioral symptoms and associated caregiver distress were assessed with the Neuropsychiatric Inventory (NPI). Results One-hundred-six patients with mild-to-moderate AD (mean age 68.6 years) were enrolled (intent to treat, n=97); most chose to have assessments conducted in Spanish. With 12 weeks of treatment, subjects showed statistically significant improvement from baseline on MMSE (P<0.0001), FOME retrieval (P=0.0042), FOME repeated retrieval (P=0.0020) and SDMT correct scores (P<0.0001). The NPI subdomain “apathy/indifference” showed statistically significant improvement (P=0.0010). The NPI Caregiver Distress scale (NPI-D) total score was statistically significantly improved (P=0.0500), suggesting a positive impact on relieving caregivers’ burden associated with patient behavior. Most patients tolerated the treatment well, with only 2 discontinuing because of adverse events. The most common (>5%) adverse events were insomnia (9.5%), dizziness (7.6%), diarrhea (5.7%) and nausea (5.7%). Conclusion The cognitive improvement and safety results from this study were consistent with those reported for donepezil in the general population. Increased awareness of AD in the Hispanic population will help more Hispanics with AD to benefit from early diagnosis and effective treatment.

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Section: Discussionsupporting

confidence: 87%

Section: Discussionsupporting

confidence: 86%

Section: Discussioncontrasting

confidence: 65%

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Effectiveness and Safety of Donepezil in Hispanic Patients with Alzheimer’s Disease: A 12-Week Open-Label Study

López

Mackell

Sun

et al. 2008

Journal of the National Medical Association

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“…Previous studies have suggested that the prevalence of dementia and AD varies by ethnicity and geographical location. [21][22][23][24][25] One extensive review of epidemiologic studies showed that the prevalence estimates of dementia vary from 1.6% in Asia to 15.3% in North America (ages 65+ years) and from 7.1% in Asia to 47.2% in North America (ages 85+ years). 26 In Northern Italy, the prevalence of dementia in the elderly above 59 years of age was 9.8% while among the elderly in Japan it was 3.8%.…”

Section: Discussionmentioning

confidence: 99%

Prevalence of dementia and associated risk factors in Middle Anatolia, Turkey

Arslantaş

Özbabalık

Metintaş

et al. 2009

Journal of Clinical Neuroscience

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“…Other factors that have been shown to affect recruitment include the process of obtaining informed consent (16), issues associated with recruitment of minority patients (17)(18)(19)(20), and the extent of inclusion and exclusion criteria (13,21). Each of these issues needs to be effectively addressed in order to attain optimal rates of clinical trial recruitment, and pilot studies of innovative approaches to overcoming these barriers are being conducted (22,23).…”

mentioning

confidence: 99%

Physicians and caregivers: Ready and waiting for increased participation in clinical research

Jones

Andrieu

Knox

et al. 2010

The Journal of nutrition, health and aging

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Progressive development of pharmacotherapy for Alzheimer's disease (AD) as well as non-pharmacological treatments is critically dependent on the timely recruitment of appropriate subjects for clinical trials. Accordingly, the IMPACT survey sought to determine the level of awareness of clinical trials and the willingness to foster patient involvement/participation in research studies. IMPACT survey participants were recruited via the Internet in equal numbers from 5 European countries-France, Germany, Italy, Spain and the United Kingdom. During April and May 2009, 250 caregivers and 500 physicians who agreed to participate in this market-based survey completed a 30-minute Web-based questionnaire that included items concerning awareness of clinical research and willingness to facilitate participation of AD patients in such research. Awareness of local clinical trials amongst both caregivers (24% overall; range by country, 14% to 34%) and physicians (19% overall; range by country, 13% to 30%) was found to be low in all countries surveyed. In contrast, the willingness of physicians to refer patients to, and caregivers to support their participation in, clinical trials was extremely high (98% and 81%, respectively). These results strongly indicate that physicians and caregivers are ready and waiting to become more involved in clinical research. Initiatives to increase awareness of clinical trials amongst caregivers and physicians and to conduct clinical trials within the geographical area of as many potential participants as possible should result in much more effective patient recruitment to AD clinical trials.

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[P‐205]: Safety and efficacy of donepezil in a 12‐week, open‐label trial in African Americans with mild to moderate Alzheimer's disease

Cited by 9 publications

References 0 publications

Effectiveness and Safety of Donepezil in Hispanic Patients with Alzheimer’s Disease: A 12-Week Open-Label Study

Effectiveness and Safety of Donepezil in Hispanic Patients with Alzheimer’s Disease: A 12-Week Open-Label Study

Prevalence of dementia and associated risk factors in Middle Anatolia, Turkey

Physicians and caregivers: Ready and waiting for increased participation in clinical research

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