Translation issues in clinical trials of dementia drugs: Position paper from the International Working Group on Harmonization of Dementia Drug Guidelines

Alzheimer Disease and Associated Disorders

Volumn 11, Issue SUPPL. 3, 1997, Pages 61-64

  Feldman, Howard ^a,l   Anand, Ravi ^b   Blesa, Rafael ^c   Dubois, Bruno ^d   Gray, Julien ^e   Homma, Akira ^f   Mohr, Erich ^g   Morris, John C ^h   Parys, Wym ⁱ   Raschig, Andreas ^j   Robillard, Alain ^k  

^a UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^b Sandoz Pharma Ltd   (Switzerland)

^c UNIVERSITY OF BARCELONA   (Spain)

^d PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

^e F HOFFMANN LA ROCHE LTD   (Switzerland)

^f TOKYO METROPOLITAN INSTITUTE OF GERONTOLOGY   (Japan)

^g Elisabeth Bruyere Research Institute   (Canada)

^h WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

ⁱ JANSSEN RESEARCH FOUNDATION   (Belgium)

^j BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

^k MAISONNEUVE ROSEMONT HOSPITAL   (Canada)

^l VANCOUVER HOSPITAL AND HEALTH SCIENCES CENTRE   (Canada)

more..

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG; NOOTROPIC AGENT;

AGED; ALZHEIMER DISEASE; ARTICLE; CLINICAL TRIAL; DEMENTIA; GERIATRIC ASSESSMENT; HUMAN; INTERNATIONAL COOPERATION; LANGUAGE; NEUROPSYCHOLOGICAL TEST; PRACTICE GUIDELINE;

AGED; ALZHEIMER DISEASE; CLINICAL TRIALS; DEMENTIA; DRUGS, INVESTIGATIONAL; GERIATRIC ASSESSMENT; HUMANS; INTERNATIONAL COOPERATION; LANGUAGE; NEUROPSYCHOLOGICAL TESTS; NOOTROPIC AGENTS; PRACTICE GUIDELINES; TRANSLATING;

EID: 17044453918     PISSN: 08930341     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (23)

1. CPMP Working Party on Efficacy of Medicinal Products. Note for guidance. Brussels: Commission of the European Communities, 1992.
2. Blessed G, Tomlinson BE, Roth M. The association between quantitative measures of dementia and of senile change in the cerebral gray matter of elderly subjects. Br J Psychiatry 1968;114:797-811.
3. Demers P, Robillard A, Lafleche G, Nash F, Heyman A, Fillenbaum G. Translation of clinical and neuropsychological instruments into French: the CERAD experience. Age Ageing 1994;23:449-51.
4. Folstein MF, Folstein S, 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.
5. Ganguli M, Ratcliff G, Huff FJ, et al. Serial sevens versus world backwards: a comparison of the two measures of attention from the MMSE. J Geriatr Psychiatry Neurol 1990;3:203-7.
6. Ganguli M, Ratcliff G, Huff FJ, et al. Effects of age, gender, and education on cognitive tests in a rural elderly community sample: norms from the Monongahela Valley Independent Elders Survey. Neuroepidemiology 1991;10:42-52.
7. Guardia J, Peña-Casanova J, Beltran-Serra I, Manero RM, Meza M, Böhm P. Versión abreviada del test Barcelona (II): puntuación global normalizada. Neurologia 1997;12:112-6.
8. Hughes CP, Berg L, Danzinger WL. A new clinical scale for the staging of dementia. Br J Psychiatry 1982;140:566-72.
9. Kameyama M, Ito E, Otomo E, et al. Guideline on clinical evaluation of cerebral circulation and metabolism improvers. Kyokai NK, ed. Guideline on clinical evaluation of new drugs. Tokyo: Yakuji Nipposha, 1995:182-213.
10. Leber P. Guidelines for the clinical evaluation of antidementia drugs. Washington, DC: U.S. Food and Drug Administration, 1990.
11. Mattis S. Mental status examination for organic mental syndrome in the elderly patient. In: Bellack L, Karasu TB, eds. Geriatrics psychiatry: a handbook for psychiatrists and primary care physicians. New York: Grune & Straton, 1976:77-121.
12. Mohr E, Feldman H, Gauthier S. Canadian guidelines for the development of antidementia therapies: a conceptual summary. Can J Neurol Sci 1995;22:62-71.
13. Morris JC, Heyman A, Mohs RC, et al. The Consortium to Establish a Registry for Alzheimer's Disease (CERAD). Part I, clinical and neuropsychological assessment of Alzheimer's disease. Neurology 1989;39: 1159-65.
14. Peña-Casanova J, Aguilar M, Beltran-Serra I, Santacruz P, Hernández G, Insa R, Pujol A, Sol JM, Blesa R. Normalización de instrumentos cognitivos y funcionales para la evaluación de demencia (NORMACODEM) (I): objetivos, contenidos y población. Neurologia 1997a;12:56-60.
15. Peña-Casanova J, Aguilar M, Santacruz P, Beltran-Serra I, Hernández G, Sol JM, Pujol A, Blesa R. Adaptación y normalización españolas de la Alzheimer's Disease Assessment Scale (ADAS) (NORMACODEM) (II). Neurologia 1997b;12:69-77.
16. Peña-Casanova J, Guardia J, Beltran-Serra I, Manero RM, Jarne A. Versión abreviada del test Barcelona (I): subtests y perfiles normales. Neurologia 1997c;12:99-111.
17. Peña-Casanova J, Meza M, Beltran-Serra I, Manero RM, Espel G, Martí A, Böhm P, Blesa R, Guardia J. Versión abreviada del test Barcelona (III): validez de criterio con el ADAS-cog. Neurologia 1997d;12:117-9.
18. Reisberg B. Functional Assessment Staging (FAST). Psychopharmacol Bull 1988;24:653-5.
19. Reisberg B, Ferris SH, de Leon MJ. The Global Deterioration Scale (GDS). Psychopharmacol Bull 1988;24:661.
20. Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry 1984;141:1356-64.
21. Study Team for Establishment of Clinical Evaluation Procedures for Cerebral Circulation and Metabolism Improvers. Guideline on clinical evaluation of cerebral circulation and metabolism improvers. Tokyo, Japan: Study Team for Establishment of Clinical Evaluation Procedures for Cerebral Circulation and Metabolism Improvers, 1986.
22. Teng EL. The Modified Mini-Mental State (3MS) examination. J Clin Psychiatry 1987;48:314-8.
23. Teunisse S, Derix MM. Measurement of activities of daily living in patients with dementia living at home: development of a questionnaire. Tijdschrift voor Gerontologie en Geriatrie 1991;22:53-9. [In Dutch.]