The objective of this proposal is to develop, cooperatively, new or improved assessment methodologies and instruments for evaluating clinical improvement in AD clinical trials. The two central questions in evaluating treatment efficacy are whether the drug has a therapeutic effect, and if so, whether the effect observed is clinically meaningful and of sufficient magnitude to outweigh possible risks. Obtaining accurate answers hinges on using well-designed protocols which employ appropriate, sensitive, reliable and clinically relevant outcome measures. Reasonably adequate measures are currently available for the four primary AD assessment categories: Measures of cognitive function (comprehensive scales and psychometric batteries), global scales, activities of daily living (ADL) scales, and non-cognitive behavioral symptom scales. However, current measures in each of these domains have significant limitations. Two additional assessment domains are of growing importance for widening patient access to clinical trials: measures for severly impaired patients, and non-English scales. Relatively little previous work has been done in these two areas. The general goal of this proposal is to capitalize on the unique expertise, experience, patient resources and staff of the Alzheimer's Disease Study Units (ADSUs) to develop improved or new outcome measures in each of these six assessment domains. To achieve this goal, we propose (1) to form subcommittees of experts for each assessment domain which will conceptualize, develop, and plan the evaluation of new measures in each domain. A Consortium Assessment Committee, consisting of a chair and the chairs of each assessment subcommittee, will plan and coordinate the overall program to develop new measures; (2) to utilize the staff and patient populations of the 30 participating ADSUs to assess the utility, reliability and validity of the new scales and tests that are developed, and (3) to field-test the utility and drug sensitivity of the new measures developed by including them as secondary outcome measures in multicenter clinical trials conducted by the ADSUs.

Agency
National Institute of Health (NIH)
Institute
National Institute on Aging (NIA)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01AG010483-10
Application #
6315218
Study Section
Project Start
2000-07-01
Project End
2001-09-14
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
10
Fiscal Year
2000
Total Cost
$228,404
Indirect Cost
Name
University of California San Diego
Department
Type
DUNS #
077758407
City
La Jolla
State
CA
Country
United States
Zip Code
92093
Rockenstein, Edward; Ostroff, Gary; Dikengil, Fusun et al. (2018) Combined Active Humoral and Cellular Immunization Approaches for the Treatment of Synucleinopathies. J Neurosci 38:1000-1014
Edmonds, Emily C; Ard, M Colin; Edland, Steven D et al. (2018) Unmasking the benefits of donepezil via psychometrically precise identification of mild cognitive impairment: A secondary analysis of the ADCS vitamin E and donepezil in MCI study. Alzheimers Dement (N Y) 4:11-18
Chen, Yun-Fei; Ni, Xiao; Fleisher, Adam S et al. (2018) A simulation study comparing slope model with mixed-model repeated measure to assess cognitive data in clinical trials of Alzheimer's disease. Alzheimers Dement (N Y) 4:46-53
Jacobs, Diane M; Ard, M Colin; Salmon, David P et al. (2017) Potential implications of practice effects in Alzheimer's disease prevention trials. Alzheimers Dement (N Y) 3:531-535
Moussa, Charbel; Hebron, Michaeline; Huang, Xu et al. (2017) Resveratrol regulates neuro-inflammation and induces adaptive immunity in Alzheimer's disease. J Neuroinflammation 14:1
Sims, Rebecca (see original citation for additional authors) (2017) Rare coding variants in PLCG2, ABI3, and TREM2 implicate microglial-mediated innate immunity in Alzheimer's disease. Nat Genet 49:1373-1384
El-Agnaf, Omar; Overk, Cassia; Rockenstein, Edward et al. (2017) Differential effects of immunotherapy with antibodies targeting ?-synuclein oligomers and fibrils in a transgenic model of synucleinopathy. Neurobiol Dis 104:85-96
Jun, Gyungah R; Chung, Jaeyoon; Mez, Jesse et al. (2017) Transethnic genome-wide scan identifies novel Alzheimer's disease loci. Alzheimers Dement 13:727-738
Tarrant, Sarah D; Bardach, Shoshana H; Bates, Kendra et al. (2017) The Effectiveness of Small-group Community-based Information Sessions on Clinical Trial Recruitment for Secondary Prevention of Alzheimer's Disease. Alzheimer Dis Assoc Disord 31:141-145
Kennedy, Richard E; Cutter, Gary R; Wang, Guoqiao et al. (2017) Challenging Assumptions About African American Participation in Alzheimer Disease Trials. Am J Geriatr Psychiatry 25:1150-1159

Showing the most recent 10 out of 294 publications