Abstract
There are many who feel that the achievement of a disease-modifying (DM) designation for a drug is an important goal in Alzheimer disease (AD) therapeutics. Several designs that might prove DM have been proposed, including randomized start, randomized withdrawal, and slope analysis. Using biomarkers such as cerebrospinal fluid assays or imaging features as primary outcome measures have also been considered a way of proving DM. The available methods for establishing DM are fraught with logistical and analytic problems. Unless the drug's benefits are large, attempts to prove DM for a truly effective drug may fail. Therefore, clinical trial designs that are the simplest to conduct and interpret are superior to those more complex approaches intended to prove DM.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 147-149 |
| Number of pages | 3 |
| Journal | Alzheimer's and Dementia |
| Volume | 2 |
| Issue number | 3 |
| DOIs | |
| State | Published - Jul 2006 |
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Keywords
- Alzheimer's disease
- Clinical trials
- Drug therapy
ASJC Scopus subject areas
- Health Policy
- Epidemiology
- Geriatrics and Gerontology
- Psychiatry and Mental health
- Cellular and Molecular Neuroscience
- Developmental Neuroscience
- Clinical Neurology
Cite this
Finding potent drugs for Alzheimer's disease is more important than proving the drugs are disease modifying. / Knopman, David S.
In: Alzheimer's and Dementia, Vol. 2, No. 3, 07.2006, p. 147-149.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Finding potent drugs for Alzheimer's disease is more important than proving the drugs are disease modifying
AU - Knopman, David S
PY - 2006/7
Y1 - 2006/7
N2 - There are many who feel that the achievement of a disease-modifying (DM) designation for a drug is an important goal in Alzheimer disease (AD) therapeutics. Several designs that might prove DM have been proposed, including randomized start, randomized withdrawal, and slope analysis. Using biomarkers such as cerebrospinal fluid assays or imaging features as primary outcome measures have also been considered a way of proving DM. The available methods for establishing DM are fraught with logistical and analytic problems. Unless the drug's benefits are large, attempts to prove DM for a truly effective drug may fail. Therefore, clinical trial designs that are the simplest to conduct and interpret are superior to those more complex approaches intended to prove DM.
AB - There are many who feel that the achievement of a disease-modifying (DM) designation for a drug is an important goal in Alzheimer disease (AD) therapeutics. Several designs that might prove DM have been proposed, including randomized start, randomized withdrawal, and slope analysis. Using biomarkers such as cerebrospinal fluid assays or imaging features as primary outcome measures have also been considered a way of proving DM. The available methods for establishing DM are fraught with logistical and analytic problems. Unless the drug's benefits are large, attempts to prove DM for a truly effective drug may fail. Therefore, clinical trial designs that are the simplest to conduct and interpret are superior to those more complex approaches intended to prove DM.
KW - Alzheimer's disease
KW - Clinical trials
KW - Drug therapy
UR - http://www.scopus.com/inward/record.url?scp=33744929621&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=33744929621&partnerID=8YFLogxK
U2 - 10.1016/j.jalz.2006.03.010
DO - 10.1016/j.jalz.2006.03.010
M3 - Article
C2 - 19595873
AN - SCOPUS:33744929621
VL - 2
SP - 147
EP - 149
JO - Alzheimer's and Dementia
JF - Alzheimer's and Dementia
SN - 1552-5260
IS - 3
ER -