A multicenter evaluation of new treatment efficacy instruments for Alzheimer's disease clinical trials: Overview and general results

Alzheimer Disease and Associated Disorders

Volumn 11, Issue SUPPL. 2, 1997, Pages

  Ferris, Steven H ^a   Mackell, Joan A ^a   Mohs, Richard ^b   Schneider, Lon S ^c   Galasko, Douglas ^d,h   Whitehouse, Peter J ^e   Schmitt, Frederick A ^f   Sano, Mary ^g   Thomas, Ronald G ^h   Ernesto, Christopher ^h   Grundman, Michael ^d,h   Schafer, Kimberly ^h   Thal, Leon J ^d,h  

^a NEW YORK UNIVERSITY MEDICAL CENTER   (United States)

^b MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

^e UNIVERSITY HOSPITALS OF CLEVELAND   (United States)

^f UNIVERSITY OF KENTUCKY   (United States)

^g Taub Institute for Research on Alzheimer's Disease and the Aging Brain and the Gertrude H Sergievsky Center   (United States)

^h UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

ADCS; Alzheimer's disease; Instrument development; Longitudinal change; Multisite clinical trials; Outcome measures

Indexed keywords

ADULT; AGED; AGITATION; ALZHEIMER DISEASE; ARTICLE; ATTENTION; BEHAVIOR; CLINICAL TRIAL; COGNITION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DAILY LIFE ACTIVITY; DISEASE SEVERITY; FEMALE; FOLLOW UP; HUMAN; MAJOR CLINICAL STUDY; MALE; MEDICAL RESEARCH; MEMORY; MULTICENTER STUDY; PRIORITY JOURNAL; PSYCHOPHARMACOTHERAPY; RELIABILITY; TIME; TREATMENT OUTCOME;

AGED; ALZHEIMER DISEASE; ANALYSIS OF VARIANCE; FEMALE; HUMANS; LONGITUDINAL STUDIES; MALE; MIDDLE AGED; PROGNOSIS; PSYCHIATRIC STATUS RATING SCALES;

EID: 0030819805     PISSN: 08930341     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (29)

1. Berg L. Clinical dementia rating (CDR). Psychopharmacol Bull 1988; 24:637-9.
2. Cohen-Mansfield J, Billig N. Agitated behaviors in the elderly. I. A conceptual review. J Am Geriatr Soc 1986;34:711-21.
3. Crook T, Ferris S, Bartus R. Assessment in geriatric psychopharmacology. New Canaan, CT: Mark Powley, 1983.
4. Feinstein AR, Josephy BR, Wells CK. Scientific and clinical problems in indexes of functional disability. Ann Intern Med 1986;105:413-20.
5. Folstein MF, Folstein SE, McHugh PR. "Mini-mental state": a practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 1975;12:189-98.
6. Gershon S, Ferris SH, Kennedy JS, et al. Methods for the evaluation of pharmacologic agents in the treatment of cognitive and other deficits in dementia. In: Prien RF, Robinson DS, eds. Clinical evaluation of psychotropic drugs: principles and guidelines. New York: Raven Press, 1994:467-99.
7. Harrell LE, Jope RS, Falgout J. Biological and neuropsychological characterization of physostigmine responders and nonresponders in Alzheimer's disease. J Am Geriatr Soc 1990;38:113-22.
8. Kluger A, Ferris SH. Scales for the assessment of Alzheimer's disease. Psychiatr Clin North Am 1991;14:309-26.
9. Leber P. Guidelines for the clinical evaluation of antidementia drugs. First draft. Rockville, MD: US Food and Drug Administration, 1990.
10. Leber P. FDA letter to sponsors recommending use of CIBIC in dementia trials. 1991.
11. Lehman E. Practicable and valid approach to evaluate the efficacy of nootropic drugs by means of rating scales. Pharmacopsychiatry 1984;17:71-5.
12. McKhann G, Drachman D, Folstein M, et al. Clinical diagnosis of Alzheimer's disease: report of the NINCDS-ADRDA Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimer's disease. Neurology 1984;34:939-44.
13. Raskin A, Niederhe G. Assessment in diagnosis and treatment of geropsychiatric patients. Psychopharmacol Bull 1988;24:501-810.
14. Reisberg B. Functional assessment staging (FAST). Psychopharmacol Bull 1988;24:653-9.
15. Reisberg B, Borenstein J, Franssen E, et al. Remediable behavioral symptomatology in Alzheimer's disease. Hosp Community Psychiatry 1986;37:1199-201.
16. Reisberg B, Ferris SH, Anand R, de Leon MJ, Schneck MK, Buttinger C, Borenstein J. Functional staging of dementia of the Alzheimer's type. Ann NY Acad Sci 1984;435:481-483.
17. Reisberg B, Ferris SH, Anand R, de Leon MJ, Schneck MK, Crook T. Clinical assessment of cognitive decline in normal aging and primary degenerative dementia: concordant ordinal measures. In: Pinchot P, Berner P, Wolf R, Thau K, eds. Psychiatry. Vol. 5. New York: Plenum Press, 1985:333-8.
18. Reisberg B, Ferris SH, de Leon MJ, Crook T. The Global Deterioration Scale (GDS). Psychopharmacol Bull 1988a;24:661-3.
19. Reisberg B, Ferris SH, de Leon MJ, et al. Stage-specific behavioral, cognitive, and in vivo changes in community residing subjects with age-associated memory impairment and primary degenerative dementia of the Alzheimer type. Drug Dev Res 1988b;15:101-14.
20. Reisberg B, Ferris SH, Kluger A. et al. Symptomatic changes in CNS aging and dementia of the Alzheimer type: cross-sectional, temporal, and remediable concomitants. In: Bergener M, Reisberg B, eds. Diagnosis and treatment of senile dementia. Berlin: Springer-Verlag, 1989:193-223.
21. Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry 1984;141:1356-64.
22. Sano M, Mackell JA, Ponton M, et al. The Spanish instrument protocol: design and implementation of a study to evaluate treatment efficacy instruments for Spanish-speaking patients with Alzheimer's disease. Alzheimer Dis Assoc Disord 1997;11(suppl 2):S57-64 (this issue).
23. Saxton J, McGonigle-Gibson KL, Swihart AA, et al. Assessment of the severely impaired patient: Description and validation of a new neuropsychological test battery. Psychol Assessment: J Consult Clin Psychol 1990;2:298-303.
24. Stern RG, Mohs RC, Davidson M, et al. A longitudinal study of Alzheimer's disease: measurement, rate and predictors of cognitive deterioration. Am J Psychiatry 1994;151:390-6.
25. Tariot PN, Mack JL, Patterson MB, et al. The Behavior Rating Scale for Dementia of the Consortium to Establish a Registry for Alzheimer's Disease. The Behavioral Pathology Committee of the Consortium to Establish a Registry for Alzheimer's Disease. Am J Psychiatry 1995;152:1349-57.
26. Weiner MF, Koss E, Wild KV, Folks DG, Tariot P, Luszczynska H, Whitehouse P. Measures of psychiatric symptoms in Alzheimer's disease: A review. Alzheimer Dis Assoc Disord 1996;10:20-30.
27. Wragg R, Jeste D. Overview of depression and psychosis in Alzheimer's disease. Am J Psychiatry 1989;146:577-87.
28. Yesavage JA, Tinklenberg JR, Hollister LE, Berger PA. Vasodilators in senile dementias: a review of the literature. Arch Gen Psychiatry 1979;36:220-3.
29. Zubenko GS, Moossy J. Major depression in primary dementia. Arch Neurol 1988;45:1182-6.