Designing dementia treatment studies: Diagnosis, efficacy criteria, and duration

European Psychiatry

Volumn 11, Issue 3, 1996, Pages 149-154

  Spiegel, R ^a   Irwin, P ^a  

^a Sandoz Pharma Ltd   (Switzerland)

Author keywords

clinical trials; dementia; guidelines; harmonization; study design

Indexed keywords

DIHYDROERGOTOXINE MESILATE; NIMODIPINE; NOOTROPIC AGENT; PIRACETAM;

CLINICAL PROTOCOL; DEMENTIA; DRUG EFFICACY; DRUG LEGISLATION; EUROPE; HUMAN; JAPAN; PRIORITY JOURNAL; REVIEW; TREATMENT PLANNING; UNITED STATES;

EID: 0029898441     PISSN: 09249338     EISSN: None     Source Type: Journal    
DOI: 10.1016/0924-9338(96)85181-9     Document Type: Article

References (28)

1. Amaducci L, Angst J, Bech P et al. Consensus Conference on the Methodology of Clinical Trials of "Nootropics", Munich, June 1989. Pharmacopsychiatry 1990;23:171-5
2. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders (Third Edition - Revised), Washington, DC: APA, 1987
3. Blessed G, Tomlinson BE, Roth M. The association between quantitative measures of dementia and of senile change in the cerebral grey matter of elderly subjects. Br J Psychiatry 1968;114:797-811
4. CPMP. CPMP Working Party on Efficacy of Medicinal Products: Antidementia Medicinal products. Draft 5. Commission of the European Communities, Brussels 1992
5. Crum RM, Anthony JC, Bassett SS, Folstein MF. Population-based norms for the mini-mental state examination by age and educational level. JAMA 1993;269:2386-91
6. De Jong R, Osterlund OW, Roy GW. Measurement of quality-of-life changes in patients with Alzheimer's Disease. Clin Therapeut 1989;11:545-54
7. FDA Task Force. Antidementia drug assessment symposium. Ad hoc FDA Dementia Assessment Task Force. Neurobiol Aging 1991;12:379-82
8. Folstein MF, Folstein SE, McHugh PR. Mini-Mental State: a practical method for grading the cognitive state of patients for the clinician. J Psychiat Res 1975;12:189-201
9. Huber F, Koeberle S, Prestele H, Spiegel R. Effects of long-term ergoloid mesylates ('Hydergine') administration in healthy pensioners: 5-year results. Curr Med Res Opin 1986;10:235-79
10. Hughes ChP, Berg L, Danzinger WL, Coben LA, Martin RL. A new clinical scale for the staging of dementia. Br J Psychiatry 1982;140:566-72
11. ICH. The 2nd International Conference on Harmonization (ICH-2). Orlando, Florida, 1993
12. Irwin P, Singer J. A guide for clinical studies with potential antipsychotic or antidepressant medications. Clin Research Practices & Drug Reg Affairs 1988;6:293-411
13. Katz S, Ford AB, Moskowitz RW, Jackson B, Jaffe M. Studies of illness in the aged: The Index of ADL, a standardized measure of biological and psychosocial function. JAMA 1963;185:914-9
14. Knapp MJ, Knopman DS, Solomon PR, Penlebury WW, Davis CS, Gracon SI. A 30-week randomized controlled trial of high-dose Tacrine in patients with Alzheimer's disease. JAMA 1994;271:985-91
15. Knopman D, Gracon S. Observations on the short-term 'natural history' of probable Alzheimer's disease in a controlled clinical trial. Neurology 1994;44:260-5
16. Lawton MP. Scales to measure competence in everyday activities. Psychopharmacol Bull 1988;24:609-14
17. Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist 1969;9:179-86
18. Leach J, Levy R. Editorial. Reflection on the NINCDS/ ADRDA criteria for the diagnosis of Alzheimer's disease. Int J Geriat Psychiat 1994;9:173-9
19. Leber P. Guidelines for the Clinical Evaluation of Antidementia Drugs. First Draft. Washington, DC: FDA, 1990
20. Leber P. Global Assessment Measures. Letter to Companies involved in antidementia research. Washington, DC: FDA, 1991
21. Lucca U, Comelli M, Tettamanti M, Tiraboschi P, Spagnoli A. Rate of progression and prognostic factors in Alzheimer's disease: a prospective study. J Amer Geriat Soc 1993;41:45-9
22. Mattis S. Mental state examination for organic mental syndromes in the elderly patient. In: Bellak L, Karasu TB, eds. Geriatric Psychiatry. New York: Grune & Stratton 1976;77-121
23. McKhann G, Drachman D, Folstein M, Katzman R, Price D, Stadlan EM. Clinical diagnosis of Alzheimer's disease. Report of the NINCDS-ADRDA Work Group. Neurology 1984;34:939-44
24. Reisberg B, Ferris SH, deLeon MJ, Crook T. The Global Deterioration Scale (GDS): An instrument for the assessment of primary degenerative dementia (PDD). Am J Psychiat 1982;139:1136-9
25. Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiat 1984;141:1356-64
26. Spiegel R, Brunner C, Ermini-Fünfschilling D et al. A new behavioral assessment scale for geriatric out- and inpatients: the NOSGER (Nurses' Observation Scale for Geriatric Patients). J Amer Geriat Soc 1991;39:339-47
27. Stern RG, Mohs RC, Davidson M, Schmeidler J, Silverman J Kramer-Ginsberg E, Searcey T, Bierer L, Davis KL. A longitudinal study of Alzheimer's disease: Measurement, rate, and predictors of cognitive deterioration. Am J Psychiat 1994;151:390-6
28. Tremmel L, Spiegel R. Clinical experience with the NOSGER (Nurses' Observation Scale for Geriatric Patients): Tentative normative data and sensitivity to change. Int J Geriat Psychiat 1993;8:311-7