Linked Life Data

9876956

Source:http://linkedlifedata.com/resource/pubmed/id/9876956

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
4
pubmed:dateCreated
1999-3-18
pubmed:abstractText
Advances in our understanding of the pathogenesis of Alzheimer disease (AD) and vascular dementia (VaD) now permit responsible discussion of therapies that may go beyond relief of cognitive and behavioral symptoms and actually slow progression of disease. The mechanisms of neuronal death and the pathologic role of glia are being elucidated, and epidemiologic studies have suggested potential protective value for anti-inflammatory drugs, estrogen, and free-radical scavengers. However, demonstrating disease-modifying drug effects for progressive conditions such as dementia can be a daunting task, fraught with clinical, statistical, and ethical dilemmas. To evaluate trial designs for demonstrating such effects, the International Working Group on Harmonization of Dementia Drug Guidelines (IWG) conducted a symposium at the Sixth International Congress on Alzheimer's Disease and Related Disorders, held July 1998 in Amsterdam. The presentations at the IWG symposium covered the two basic designs currently being used in clinical trials, survival analysis and staggered-start/withdrawal, in addition to clinical data generated from the National Institute on Aging Alzheimer's Disease Cooperative Study vitamin E/selegiline trial in patients with AD and the phase III clinical studies of propentofylline in patients with AD and VaD. It is hoped that this article will open a dialogue among investigators and regulatory authorities regarding appropriate trial designs to support a regulatory claim for disease-modifying effects.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Dec
pubmed:issn
0893-0341
pubmed:author
pubmed:issnType
Print
pubmed:volume
12
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
281-94
pubmed:dateRevised
2007-11-15
pubmed:meshHeading
pubmed:year
1998
pubmed:articleTitle
Clinical trial designs for demonstrating disease-course-altering effects in dementia.
pubmed:affiliation
University Alzheimer Center, Fairhill Center for Aging, Cleveland, Ohio, USA.
pubmed:publicationType
Congresses, Research Support, Non-U.S. Gov't