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  1. Book: A multicenter evaluation of new treatment efficacy instruments for Alzheimer's disease clinical trials

    Ferris, Steven H.

    results of the instrument development project of the Alzheimer's disease cooperative study

    (Alzheimer disease and associated disorders ; 11, Suppl. 2)

    1997  

    Author's details guest ed. Steven H. Ferris
    Series title Alzheimer disease and associated disorders ; 11, Suppl. 2
    Alzheimer disease & associated disorders
    Collection Alzheimer disease & associated disorders
    Keywords Dementia / drug therapy ; Treatment Outcome ; Outcome Assessment (Health Care)
    Language English
    Size V, S72, [36] S. : graph. Darst.
    Publisher Lippincott-Raven
    Publishing place Philadelphia, PA
    Publishing country United States
    Document type Book
    HBZ-ID HT007751771
    Database Catalogue ZB MED Medicine, Health

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  2. Article ; Online: Experimental Aspects of Measuring the Vial Heat Transfer Coefficient in Pharmaceutical Freeze-Drying.

    Wegiel, Lindsay A / Ferris, Steven J / Nail, Steven L

    AAPS PharmSciTech

    2018  Volume 19, Issue 4, Page(s) 1810–1817

    Abstract: One of the current methods for cycle optimization in primary drying to is develop a graphical design space based on quality by design (QbD). In order to construct the design space, the vial heat transfer coefficient ( ... ...

    Abstract One of the current methods for cycle optimization in primary drying to is develop a graphical design space based on quality by design (QbD). In order to construct the design space, the vial heat transfer coefficient (K
    MeSH term(s) Desiccation/methods ; Drug Packaging/methods ; Drug Packaging/standards ; Freeze Drying/methods ; Glass/chemistry ; Hot Temperature ; Technology, Pharmaceutical/methods
    Language English
    Publishing date 2018-04-03
    Publishing country United States
    Document type Journal Article
    ISSN 1530-9932
    ISSN (online) 1530-9932
    DOI 10.1208/s12249-018-0998-z
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Language impairment in Alzheimer's disease and benefits of acetylcholinesterase inhibitors.

    Ferris, Steven H / Farlow, Martin

    Clinical interventions in aging

    2013  Volume 8, Page(s) 1007–1014

    Abstract: Alzheimer's disease is characterized by progressively worsening deficits in several cognitive domains, including language. Language impairment in Alzheimer's disease primarily occurs because of decline in semantic and pragmatic levels of language ... ...

    Abstract Alzheimer's disease is characterized by progressively worsening deficits in several cognitive domains, including language. Language impairment in Alzheimer's disease primarily occurs because of decline in semantic and pragmatic levels of language processing. Given the centrality of language to cognitive function, a number of language-specific scales have been developed to assess language deficits throughout progression of the disease and to evaluate the effects of pharmacotherapy on language function. Trials of acetylcholinesterase inhibitors, used for the treatment of clinical symptoms of Alzheimer's disease, have generally focused on overall cognitive effects. However, in the current report, we review data indicating specific beneficial effects of acetylcholinesterase inhibitors on language abilities in patients with Alzheimer's disease, with a particular focus on outcomes among patients in the moderate and severe disease stages, during which communication is at risk and preservation is particularly important.
    MeSH term(s) Alzheimer Disease/complications ; Cholinesterase Inhibitors/therapeutic use ; Communication Disorders/drug therapy ; Communication Disorders/physiopathology ; Donepezil ; Galantamine/therapeutic use ; Humans ; Indans/therapeutic use ; Outcome Assessment, Health Care ; Phenylcarbamates/therapeutic use ; Piperidines/therapeutic use ; Rivastigmine
    Chemical Substances Cholinesterase Inhibitors ; Indans ; Phenylcarbamates ; Piperidines ; Galantamine (0D3Q044KCA) ; Donepezil (8SSC91326P) ; Rivastigmine (PKI06M3IW0)
    Language English
    Publishing date 2013-08-02
    Publishing country New Zealand
    Document type Journal Article ; Review
    ZDB-ID 2364924-0
    ISSN 1178-1998 ; 1176-9092
    ISSN (online) 1178-1998
    ISSN 1176-9092
    DOI 10.2147/CIA.S39959
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article: Supplement editorial: alzheimer disease.

    Ferris, Steven H

    Alzheimer disease and associated disorders

    2006  Volume 20, Issue 4 Suppl 3, Page(s) S107–8

    MeSH term(s) Aged ; Alzheimer Disease/diagnosis ; Alzheimer Disease/epidemiology ; Alzheimer Disease/prevention & control ; Humans ; Neuropsychological Tests ; Population Dynamics ; Primary Prevention
    Language English
    Publishing date 2006-10
    Publishing country United States
    Document type Editorial
    ZDB-ID 1002700-2
    ISSN 1546-4156 ; 0893-0341
    ISSN (online) 1546-4156
    ISSN 0893-0341
    DOI 10.1097/01.wad.0000213875.63171.87
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article: General measures of cognition.

    Ferris, Steven H

    International psychogeriatrics

    2003  Volume 15 Suppl 1, Page(s) 215–217

    Abstract: A general cognitive performance battery is needed as a primary outcome in vascular dementia clinical trials. Because there is considerable overlap between vascular dementia and Alzheimer's disease (AD) in the pattern of cognitive impairment, a reasonable ...

    Abstract A general cognitive performance battery is needed as a primary outcome in vascular dementia clinical trials. Because there is considerable overlap between vascular dementia and Alzheimer's disease (AD) in the pattern of cognitive impairment, a reasonable approach to developing an optimal vascular dementia battery is to begin with a widely used AD measure and improve its sensitivity to the cognitive domains that are more prominent in vascular dementia. Thus the VaDAS-cog has evolved, which comprises the ADAS-cog with additional frontal lobe subtests covering attention, working memory, executive function, and verbal fluency. Validation of this new cognitive instrument will be supported by its successful use in vascular dementia clinical trials.
    MeSH term(s) Aged ; Alzheimer Disease/complications ; Alzheimer Disease/pathology ; Cognition Disorders/diagnosis ; Cognition Disorders/etiology ; Dementia, Vascular/complications ; Dementia, Vascular/pathology ; Frontal Lobe/pathology ; Humans ; Neuropsychological Tests ; Reproducibility of Results
    Language English
    Publishing date 2003
    Publishing country England
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, U.S. Gov't, P.H.S. ; Validation Studies
    ZDB-ID 1038825-4
    ISSN 1741-203X ; 1041-6102
    ISSN (online) 1741-203X
    ISSN 1041-6102
    DOI 10.1017/S1041610203009220
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article: Evaluation of memantine for the treatment of Alzheimer's disease.

    Ferris, Steven H

    Expert opinion on pharmacotherapy

    2003  Volume 4, Issue 12, Page(s) 2305–2313

    Abstract: Increasing evidence suggests that disturbances in glutamatergic activity play an important role in Alzheimer's disease (AD). Excessive glutamate-mediated activation of NMDA receptors, for example, may contribute to the neuronal death that characterises ... ...

    Abstract Increasing evidence suggests that disturbances in glutamatergic activity play an important role in Alzheimer's disease (AD). Excessive glutamate-mediated activation of NMDA receptors, for example, may contribute to the neuronal death that characterises AD. On the other hand, physiological activation of the NMDA receptor appears necessary for normal cognitive function. Therefore, compounds that finely modulate NMDA receptor activity hold promise as treatments for AD. Memantine (Namenda, Axura, Ebixa; Forest Laboratories, Inc., Merz Pharmaceuticals GmbH, H. Lundbeck A/S) is a low-moderate affinity, uncompetitive NMDA-receptor antagonist that appears to block pathological, but not physiological, activation of the NMDA receptor. Consequently, therapeutic doses of the drug are well-tolerated and do not seem to interfere with the acquisition or processing of cognitive information. Memantine has been shown to improve symptoms and reduce the rate of clinical deterioration among patients with moderate-to-severe AD and was approved in the US for this indication in October 2003. This review provides a brief rationale for the development of memantine as a therapy for AD, as well as an overview of the pharmacology, clinical efficacy, safety and tolerability of this novel therapeutic agent.
    MeSH term(s) Alzheimer Disease/drug therapy ; Alzheimer Disease/economics ; Antiparkinson Agents/adverse effects ; Antiparkinson Agents/pharmacology ; Antiparkinson Agents/therapeutic use ; Clinical Trials as Topic ; Cost-Benefit Analysis ; Humans ; Memantine/adverse effects ; Memantine/pharmacology ; Memantine/therapeutic use
    Chemical Substances Antiparkinson Agents ; Memantine (W8O17SJF3T)
    Language English
    Publishing date 2003-08-15
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2001535-5
    ISSN 1465-6566
    ISSN 1465-6566
    DOI 10.1517/14656566.4.12.2305
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article: Clinical trials in AD: are current formats and outcome measures adequate?

    Ferris, Steven H

    Alzheimer disease and associated disorders

    2002  Volume 16 Suppl 1, Page(s) S13–7

    Abstract: Great strides have been made in the measurement of outcomes and treatment efficacy in clinical trials of Alzheimer disease (AD) drugs during the past 25 years. Several sensitive, reliable, and valid clinical outcome measures have been developed. The ... ...

    Abstract Great strides have been made in the measurement of outcomes and treatment efficacy in clinical trials of Alzheimer disease (AD) drugs during the past 25 years. Several sensitive, reliable, and valid clinical outcome measures have been developed. The methodology, trial design, and outcome measures for demonstrating symptomatic benefits of an AD drug are now established. However, a greater challenge lies ahead. Major advances in fundamental knowledge about the pathophysiology of the disease and in animal models have transformed the focus of current efforts to developing and testing therapies that may actually slow disease progression, delay the onset of symptoms, and even ultimately prevent the disease. The long-duration trials that will likely be necessary to demonstrate an effect on disease progression will be costly and difficult. Proof-of-concept trials and subsequent long-term trials could gain power and efficiency from use of biologic markers of underlying disease severity, but currently available biologic markers are not ideal. A major barrier to such trials is their size and cost. One approach to reducing the cost would be to recruit "enriched" samples of subjects who are at greater risk of developing AD during the trial than the general, elderly population. The major effort required to screen and recruit large numbers of subjects for such trials also contributes to the cost. Probably the biggest problem currently is the enormous effort and cost of conducting periodic clinical evaluations to determine if subjects have declined or developed dementia. Research to develop more efficient assessment methods is clearly needed. Data acquisition over the Internet is potentially efficient and attractive and may become practical as Internet accessibility increases.
    MeSH term(s) Alzheimer Disease/drug therapy ; Animals ; Clinical Trials as Topic/methods ; Humans ; Outcome Assessment (Health Care)/methods
    Language English
    Publishing date 2002-06-09
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 1002700-2
    ISSN 1546-4156 ; 0893-0341
    ISSN (online) 1546-4156
    ISSN 0893-0341
    DOI 10.1097/00002093-200200001-00003
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Cognitive Efficacy (SIB) of 13.3 Versus 4.6 mg/24 h Rivastigmine Patch in Severe Alzheimer's Disease.

    Isaacson, Richard S / Ferris, Steven / Velting, Drew M / Meng, Xiangyi

    American journal of Alzheimer's disease and other dementias

    2015  Volume 31, Issue 3, Page(s) 270–277

    Abstract: Severe Impairment Battery (SIB) data from the 24-week, randomized, double-blind ACTivities of daily living and cognitION (ACTION) study suggest that patients with severe Alzheimer's disease (AD) benefit from treatment with 13.3 versus 4.6 mg/24 h ... ...

    Abstract Severe Impairment Battery (SIB) data from the 24-week, randomized, double-blind ACTivities of daily living and cognitION (ACTION) study suggest that patients with severe Alzheimer's disease (AD) benefit from treatment with 13.3 versus 4.6 mg/24 h rivastigmine patch. The objective of this retrospective analysis was to further examine the cognitive efficacy of 13.3 versus 4.6 mg/24 h rivastigmine patch on individual SIB items, and SIB domains derived using factor analysis of these items. Change from baseline at Week 24 on 9 new factor-defined domains and individual items was calculated and compared using effect sizes (Cohen's d). Numerically less decline was observed with 13.3 versus 4.6 mg/24 h patch on all domains and the majority of individual items. Largest least squares mean treatment differences were observed on "visuospatial reasoning," "object naming," "recognition," "design copying," "social agency," "ideational praxis," and "comprehension" domains. These findings suggest 13.3 mg/24 h rivastigmine patch demonstrates broad cognitive efficacy across a range of SIB items and domains in patients with severe AD.
    MeSH term(s) Activities of Daily Living ; Aged ; Aged, 80 and over ; Alzheimer Disease/complications ; Alzheimer Disease/drug therapy ; Cholinesterase Inhibitors/administration & dosage ; Cholinesterase Inhibitors/pharmacology ; Cognition Disorders/drug therapy ; Cognition Disorders/etiology ; Double-Blind Method ; Female ; Humans ; Male ; Middle Aged ; Outcome Assessment, Health Care ; Retrospective Studies ; Rivastigmine/administration & dosage ; Rivastigmine/pharmacology ; Severity of Illness Index ; Transdermal Patch
    Chemical Substances Cholinesterase Inhibitors ; Rivastigmine (PKI06M3IW0)
    Language English
    Publishing date 2015-09-14
    Publishing country United States
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 1283069-0
    ISSN 1938-2731 ; 0895-5336 ; 1082-5207 ; 1533-3175
    ISSN (online) 1938-2731
    ISSN 0895-5336 ; 1082-5207 ; 1533-3175
    DOI 10.1177/1533317515603687
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article: Rivastigmine in moderately severe-to-severe Alzheimer's disease: Severe Impairment Battery factor analysis.

    Ferris, Steven / Karantzoulis, Stella / Somogyi, Monique / Meng, Xiangyi

    Alzheimer's research & therapy

    2013  Volume 5, Issue 6, Page(s) 63

    Abstract: Introduction: The Severe Impairment Battery (SIB) is validated for assessing cognition in patients with severe dementia. The current analysis aimed to further investigate the cognitive efficacy of rivastigmine capsules, as assessed by SIB factor scores, ...

    Abstract Introduction: The Severe Impairment Battery (SIB) is validated for assessing cognition in patients with severe dementia. The current analysis aimed to further investigate the cognitive efficacy of rivastigmine capsules, as assessed by SIB factor scores, in patients with moderately severe-to-severe Alzheimer's disease (AD).
    Methods: This was a retrospective analysis of a 26-week, multicenter, randomized, double-blind, placebo-controlled study of oral rivastigmine conducted in Spain. Previously reported outcome measures included the full SIB. Current analyses examined calculated scores and effect sizes for the change from baseline at Week 26 on: newly defined SIB subscales (derived by a factor analysis of the 40 SIB items, using the PROC FACTOR function (SAS)); previously defined memory, language and praxis subscales (derived by previous analysis of the nine SIB domains); and the individual SIB items. Treatment differences were assessed.
    Results: SIB data were provided by 104 rivastigmine-treated patients and 106 patients receiving placebo (Intent-To-Treat Last Observation Carried Forward population). Significantly less decline was observed on the previously defined memory and language subscales, and the newly defined working memory/memory subscale in rivastigmine-treated patients (all P < 0.05 versus placebo). Calculation of effect sizes demonstrated numerically greater efficacy of rivastigmine versus placebo on each of the subscales, and a broad range of SIB items; greatest effect sizes were observed on SIB items assessing the current month (effect size = 0.30) and digit span series (effect size = 0.33).
    Conclusions: These data suggest the observed efficacy of rivastigmine in moderately severe-to-severe AD is likely a cumulative effect across a range of tasks. Rivastigmine demonstrates broad cognitive efficacy in this patient population.
    Language English
    Publishing date 2013-12-18
    Publishing country England
    Document type Journal Article
    ZDB-ID 2506521-X
    ISSN 1758-9193
    ISSN 1758-9193
    DOI 10.1186/alzrt229
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: The Utility of the Cognitive Function Instrument (CFI) to Detect Cognitive Decline in Non-Demented Older Adults.

    Li, Clara / Neugroschl, Judith / Luo, Xiaodong / Zhu, Carolyn / Aisen, Paul / Ferris, Steven / Sano, Mary

    Journal of Alzheimer's disease : JAD

    2017  Volume 60, Issue 2, Page(s) 427–437

    Abstract: Background: Subjective cognitive complaint is a sensitive marker of decline.: Objective: This study aimed to (1) examine reliability of subjective cognitive complaint using the Cognitive Function Instrument (CFI), and (2) assess the utility of the ... ...

    Abstract Background: Subjective cognitive complaint is a sensitive marker of decline.
    Objective: This study aimed to (1) examine reliability of subjective cognitive complaint using the Cognitive Function Instrument (CFI), and (2) assess the utility of the CFI to detect cognitive decline in non-demented elders.
    Methods: Data from a four-year longitudinal study at multiple Alzheimer's Disease Cooperative Study (ADCS) sites were extracted (n = 644). Of these, 497 had Clinical Dementia Rating (CDR) global scores of 0 and 147 had a CDR of 0.5. Mean age and education were 79.5±3.6 and 15.0±3.1 years, respectively. All participants and their study partners completed the subject and study partner CFI yearly. Modified Mini-Mental State Exam (mMMSE) and Free and Cued Selective Reminding Test (FCSRT) were administered. Scores below the predetermined cut-off scores on either measure at annual visit were triggers for a full diagnostic evaluation. Cognitive decline was defined by the absence/presence of the trigger.
    Results: Three-month test retest reliability showed that inter-class coefficients for subject and study partner CFI were 0.76 and 0.78, respectively. Generalized estimating equation method revealed that both subject and study partner CFI change scores and scores from previous year were sensitive to cognitive decline in the CDR 0 group (p < 0.05). In the CDR 0.5 group, only the study partner CFI change score predicted cognitive decline (p < 0.05).
    Conclusion: Cognitive decline was predicted differentially by CDR level with subject CFI scores providing the best prediction for those with CDR 0 while study partner CFI predicted best for those at CDR 0.5.
    MeSH term(s) Aged ; Aged, 80 and over ; Aging/psychology ; Cognition ; Cognitive Dysfunction/physiopathology ; Cognitive Dysfunction/psychology ; Female ; Humans ; Male ; Mental Status and Dementia Tests ; Neuropsychological Tests ; Reproducibility of Results ; Surveys and Questionnaires
    Language English
    Publishing date 2017-08-31
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 1440127-7
    ISSN 1875-8908 ; 1387-2877
    ISSN (online) 1875-8908
    ISSN 1387-2877
    DOI 10.3233/JAD-161294
    Database MEDical Literature Analysis and Retrieval System OnLINE

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