An update, I guess -- on new research on what appears to be one of the most popular Alzheimer's drugs on the market:
Here's some introductory information regarding the primary source of evidence:
The American Academy of Neurology - AAN -- from the U.S. Department of Health and Human Services:
American Academy of Neurology - AAN
Organization URL(s)
memberservices@aan.com
www.aan.com
Other Contact Information
1080 Montreal Avenue
St. Paul, MN 55116
800-879-1960 (Voice - Toll-free)
651-695-2717 (Voice)
651-695-2791 (FAX)
Description
The American Academy of Neurology (AAN) is a professional society composed of neurologists and professionals in related fields who share a common goal of continued growth and development of the neurological sciences.
Online Resources
Find a Neurologist
http://www.aan.com/membersearch/
Print Resources
The Academy publishes several brochures on neurology which are used by members for patient information. The Patient Information Guide for Neurology lists organizations which can supply information and materials on specific diseases. The publication, Neurologist, describes what a neurologist is and does. Serial publications: Neurology (journal), monthly; AANews (newsletter), monthly.
Here is some info from wikipedia on AAN:
The American Academy of Neurology (AAN) is a professional society for neurologists and neuroscientists. As a medical specialty society it was established in 1949 to advance the art and science of neurology, and thereby promote the best possible care for patients with neurological disorders.
Annual Meeting The annual meeting of the AAN is attended by more than 15,000 neurologists and neuroscientists from the US and abroad. The 2007 meeting will be in Boston featuring scientific presentations and educational courses. Plenary presentations on three days will highlight cutting edge clinical, translational and basic research. The annual "Future of Neuroscience" conference is titled "Therapies of Genetic Disorders" and will feature talks on enzyme replacement, gene therapy, siRNA, and stem cells ([1]).
Here is the study abstract:
Link to study abstract
NEUROLOGY 2007;69:459-469
© 2007 American Academy of Neurology
Donepezil preserves cognition and global function in patients with severe Alzheimer disease
S. E. Black, MD, R. Doody, MD, H. Li, PhD, T. McRae, MD, K. M. Jambor, MA, Y. Xu, PhD, Y. Sun, PhD, C. A. Perdomo, MS and S. Richardson, PhD
From the Division of Neurology (S.E.B.), Department of Medicine and Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, University of Toronto, Ontario, Canada; Alzheimer's Disease and Memory Disorders Center (R.D.), Baylor College of Medicine, Houston, TX; Eisai Inc. (H.L., Y.S., S.R.), Teaneck, NJ; Worldwide Neurosciences, Pfizer Global Pharmaceuticals (T.M.), Pfizer Inc. (Y.X.), New York, NY; PPSI (K.M.J.), Stamford, CT; and Biostatistics (C.A.P.), Eisai Medical Research Inc., Ridgefield Park, NJ.
Address correspondence and reprint requests to Dr. Sandra Black, LC Campbell Cognitive Neurology Research Unit, Sunnybrook Health Sciences Centre, Room A421, 2075 Bayview Avenue, Toronto, ON M4N 3M5, Canada sandra.black@sunnybrook.ca
Objective: To evaluate the efficacy and safety of donepezil for severe Alzheimer disease (AD).
Methods: Patients with severe AD (Mini-Mental State Examination [MMSE] scores 1 to 12 and Functional Assessment Staging [FAST] scores 6) were enrolled in this multinational, double-blind, placebo-controlled trial at 98 sites. Patients were randomized to donepezil 10 mg daily or placebo for 24 weeks. Primary endpoints were the Severe Impairment Battery (SIB) and Clinician's Interview-Based Impression of Change-Plus caregiver input (CIBIC-Plus). Secondary endpoints included the MMSE, the Alzheimer Disease Cooperative Study-Activities of Daily Living-severe version (ADCS-ADL-sev), the Neuropsychiatric Inventory (NPI), the Caregiver Burden Questionnaire (CBQ), and the Resource Utilization for Severe Alzheimer Disease Patients (RUSP). Efficacy analyses were performed in the intent-to-treat (ITT) population using last post-baseline observation carried forward (LOCF). Safety assessments were performed for patients receiving 1 dose of donepezil or placebo.
Results: Patients were randomized to donepezil (n = 176) or placebo (n = 167). Donepezil was superior to placebo on SIB score change from baseline to endpoint (least squares mean difference 5.32; p = 0.0001). CIBIC-Plus and MMSE scores favored donepezil at endpoint (p = 0.0473 and p = 0.0267). Donepezil was not significantly different from placebo on the ADCS-ADL-sev, NPI, CBQ, or RUSP. Adverse events reported were consistent with the known cholinergic effects of donepezil and with the safety profile in patients with mild to moderate AD.
Conclusion: Patients with severe AD demonstrated greater efficacy compared to placebo on measures of cognition and global function.
Supplemental data at www.neurology.org
Supported by Eisai Inc. and Pfizer Inc.
Disclosure: Sandra Black, MD, reports receiving contract research grants not reported in this article in excess of $10,000 per year and receiving honoraria for ad hoc consulting and CME in excess of $10,000 per year during the course of the study. Rachelle Doody, MD, reports receiving contract research grants not reported in this article in excess of $10,000 per year. Honglan Li, PhD, reports being a current employee of the sponsor. Thomas McRae, MD, reports being a current employee of the sponsor. Kyle Marie Jambor, MA, reports being funded by the sponsors to provide editorial support in the preparation of the manuscript. Yikang Xu, PhD, reports having equity or ownership interest in the sponsor in excess of $10,000 per year and is a current employee of the sponsor. Yijun Sun, PhD, reports being a current employee of the sponsor. Carlos Perdomo, MS, reports being a current employee of the sponsor. Sharon Richardson, PhD, reports being a current employee of the sponsor.
Received September 16, 2006. Accepted in final form March 2, 2007.
For a "mainstream" version of this story, please click
here to read: "
Health Day News: Aricept Eases Symptoms of Severe Alzheimer's Study finds the drug works, just as it does in milder cases."... -- FYI:
The tests run on patients (severe AD (Mini-Mental State Examination [MMSE] scores 1 to 12 and Functional Assessment Staging [FAST] scores 6))
At the "primary endpoints" the following tests were run:
1. Severe Impairment Battery (SIB)
More information on SIB:
Vol. 51 No. 1, January 1994
ARTICLE
Severe impairment battery. A neuropsychological test for severely demented patients
M. Panisset, M. Roudier, J. Saxton and F. Boller
McGill Center for Studies on Aging, St-Mary's Hospital, Montreal, Quebec.
OBJECTIVE: Patients with progressive dementia invariably evolve to a stage where they can no longer be tested by standard neuropsychological tests. We studied the use of the Severe Impairment Battery (SIB) in such patients. DESIGN: Case series. SETTING: Geriatric long-term facility. PATIENTS: Sixty-nine patients who met the criteria of the Diagnostic and Statistical Manual for Mental Disorders, Revised Third Edition, for dementia were selected. The diagnosis of probable Alzheimer's disease was established according to the guidelines suggested by the National Institute of Neurologic and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association. There were 18 men and 51 women. The mean age of the population was 82.99 +/- 5.66 years. The mean Mini-Mental State Examination (MMSE) score was 10.71 +/- 6.14. MAIN OUTCOME MEASURE: To characterize the cognitive profile and evolution of severely demented patients by means of the SIB. RESULTS: The mean score on the SIB was 92.52 +/- 31.92, with a possible maximum of 133 points. Subgroups of patients with the most severe degree of dementia (MMSE scores of 0 to 5 and 6 to 11) showed significant differences in their scores on the SIB. In contrast, no differences were found between subgroups with MMSE scores of 6 to 11, 12 to 17, and greater than 17. Fifteen patients who had MMSE scores of less than 6 had SIB scores ranging from 7 to 81. All cognitive domains showed a deterioration across the four severity groups as determined by the MMSE scores and also during a longitudinal study performed on 26 patients. CONCLUSION: Our study indicates that the SIB is useful for the neuropsychological evaluation of severely demented patients and for their follow-up.
2. Clinician's Interview-Based Impression of Change-Plus caregiver input (CIBIC-Plus)
Information regarding Clinician's Interview-Based Impression of Change-Plus caregiver input (CIBIC-Plus):
Vol. 23, No. 2, 2007
Original Research Article
Reliability Study on the Japanese Version of the Clinician's Interview-Based Impression of Change
Analysis of Subscale Items and 'Clinician's Impression'
Yu Nakamuraa, Akira Hommab, Shinichi Kobunec, Yosuke Tachibanad, Keizo Satohd, Isao Takamic, Shinji Nagaid, Masanao Sakaie, Hiroshi Fukutaf, Hiroaki Matsudag, Hideaki Hashimotoh, Tadashi Kusunokii, the SKETCH Study Group
aKagawa University, Kita-gun, and
bTokyo Metropolitan Institute of Gerontology,
cNovartis Pharma K.K.,
dAstellas Pharma Inc.,
eDaiichi Asubio Pharma Co. Ltd.,
fDaiichi Pharmaceutical Co. Ltd.,
gNippon Boehringer Ingelheim Co. Ltd.,
hJanssen Pharmaceutical K.K., and
iJapanese Society for Pharmacoepidemiology, Tokyo, Japan
Address of Corresponding Author
Dementia and Geriatric Cognitive Disorders 2007;23:104-115 (DOI: 10.1159/000097596)
Abstract
Background/Aims: The Japanese version of the Clinician's Interview-Based Impression of Change plus Caregiver Input (CIBIC-plus J) consists of 3 subscales: Disability Assessment of Dementia Scale (DAD), Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD), and Mental Function Impairment Scale (MENFIS), as well as the Clinician's Global Impression of Change (CGIC). While the interrater reliability of CGIC has already been reported, that of the 3 subscales has not. The aim of the present report was to examine the reliabilities of the subscale items and investigate their relationships with CGIC. Methods: Eleven raters who were clinical physicians watched videotapes of 20 patients with Alzheimer's disease, completed the CIBIC-plus J assessment form, and assigned a CGIC score to the patients. Reliability was assessed using the kappa coefficient. Results: The kappa coefficient of the subscale items was in most instances higher than that of CGIC (0.453) and substantial reliability was observed. The Spearman rank correlation that was calculated between CGIC and the total score change of items was very high for MENFIS (0.990) and DAD (0.910), and moderate for Behave-AD items (0.576). The incidence of comments by the raters was highest for MENFIS (89%), followed by DAD (70%). The incidence was low for Behave-AD items (48%). Conclusion: Based on the results, it is concluded that DAD, Behave-AD, and MENFIS are necessary constituents of CIBIC-plus J, and indispensable for the reliability of CGIC.
Copyright © 2007 S. Karger AG, Basel
Yu Nakamura, MD, PhD
Department of Neuropsychiatry, Kagawa University School of Medicine
1750-1 Ikenobe, Miki-cho
Kita-gun, Kagawa 761-0793 (Japan)
Tel. +81 87 891 2167, Fax +81 87 891 2168, E-Mail yunaka@med.kagawa-u.ac.jp
Accepted: September 6, 2006
Published online: November 28, 2006
Number of Print Pages : 12
Number of Figures : 2, Number of Tables : 4, Number of References : 15
At "secondary endpoints" the following tests were run:
1. The MMSE (Mini Mental State Examination)
Click here for more information on MMSE2. The Alzheimer Disease Cooperative Study-Activities of Daily Living-severe version (ADCS-ADL-sev)
(I can't find any reliable online info on this, can anyone else?)
3. The Neuropsychiatric Inventory (NPI)
Click here for more information on NPI4. The Caregiver Burden Questionnaire (CBQ)
I can't seem to find much info online regarding CBQ, can anyone else?
5. The Resource Utilization for Severe Alzheimer Disease Patients (RUSP)
(I can't find any reliable online info on this, can anyone else?)
Thoughts or comments?
Take care.