Skip to main content
NCBI home page
Journal of Neurology, Neurosurgery, and Psychiatry logoLink to Journal of Neurology, Neurosurgery, and Psychiatry
. 1991 Feb;54(2):178–181. doi: 10.1136/jnnp.54.2.178

Clinical trials in Alzheimer's disease. A report from the Medical Research Council Alzheimer's Disease Clinical Trials Committee.

M Swash 1, D N Brooks 1, N E Day 1, C D Frith 1, R Levy 1, C P Warlow 1
PMCID: PMC1014359  PMID: 1843446

Abstract

Recent advances in Alzheimer's disease imply a need for adequate clinical trials of new treatments which require careful design. The disorder is progressive and shows clinical heterogeneity. While large-scale trials of elderly subjects are appropriate in relation to assessment of drugs or other treatments designed to prevent progression of the disorder, the outcome measurements in such biological treatment trials require careful planning. Studies of individual patients are relevant for answering certain specific questions. Relatively short cross-over trial designs may be appropriate to some pharmacological studies. The choice of neuropsychological instruments for measuring change is critically important, particularly in excluding test/retest artefact and in avoiding floor and ceiling effects. Test scales designed for assessment of specific neuropsychological deficits, or forming part of standard IQ assessments are unlikely to prove robust. Tests can be selected and developed for individual patients, but generalisation of the results of such experiments to the disease as a whole is not inevitable. There is a need to develop psychological instruments for measuring change that are robust and relevant to the clinical problem of progressive dementia.

Full text

PDF
178

Selected References

These references are in PubMed. This may not be the complete list of references from this article.

  1. Beller S. A., Overall J. E., Swann A. C. Efficacy of oral physostigmine in primary degenerative dementia. A double-blind study of response to different dose level. Psychopharmacology (Berl) 1985;87(2):147–151. doi: 10.1007/BF00431798. [DOI] [PubMed] [Google Scholar]
  2. Blessed G., Tomlinson B. E., 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 Jul;114(512):797–811. doi: 10.1192/bjp.114.512.797. [DOI] [PubMed] [Google Scholar]
  3. Bowen D. M., White P., Flack R. H., Smith C. B., Davison A. N. Brain-decarboxylase activities as indices of pathological change in senile dementia. Lancet. 1974 Jun 22;1(7869):1247–1249. doi: 10.1016/s0140-6736(74)90003-8. [DOI] [PubMed] [Google Scholar]
  4. Folstein M. F., Folstein S. E., McHugh P. R. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189–198. doi: 10.1016/0022-3956(75)90026-6. [DOI] [PubMed] [Google Scholar]
  5. Folstein M., Anthony J. C., Parhad I., Duffy B., Gruenberg E. M. The meaning of cognitive impairment in the elderly. J Am Geriatr Soc. 1985 Apr;33(4):228–235. doi: 10.1111/j.1532-5415.1985.tb07109.x. [DOI] [PubMed] [Google Scholar]
  6. Hart S. Language and dementia: a review. Psychol Med. 1988 Feb;18(1):99–112. doi: 10.1017/s0033291700001938. [DOI] [PubMed] [Google Scholar]
  7. Henderson A. S., Huppert F. A. The problem of mild dementia. Psychol Med. 1984 Feb;14(1):5–11. doi: 10.1017/s0033291700003020. [DOI] [PubMed] [Google Scholar]
  8. Hughes C. P., Berg L., Danziger W. L., Coben L. A., Martin R. L. A new clinical scale for the staging of dementia. Br J Psychiatry. 1982 Jun;140:566–572. doi: 10.1192/bjp.140.6.566. [DOI] [PubMed] [Google Scholar]
  9. Huppert F. A., Tym E. Clinical and neuropsychological assessment of dementia. Br Med Bull. 1986 Jan;42(1):11–18. doi: 10.1093/oxfordjournals.bmb.a072089. [DOI] [PubMed] [Google Scholar]
  10. Kuriansky J. B., Gurland B. J., Fleiss J. L., Cowan D. The assessment of self-care capacity in geriatric psychiatric patients by objective and subjective methods. J Clin Psychol. 1976 Jan;32(1):95–102. doi: 10.1002/1097-4679(197601)32:1<95::aid-jclp2270320129>3.0.co;2-j. [DOI] [PubMed] [Google Scholar]
  11. Lawton M. P., Brody E. M. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179–186. [PubMed] [Google Scholar]
  12. McKhann G., Drachman D., Folstein M., Katzman R., Price D., Stadlan E. M. 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 Jul;34(7):939–944. doi: 10.1212/wnl.34.7.939. [DOI] [PubMed] [Google Scholar]
  13. Mohs R. C., Davis K. L. A signal detectability analysis of the effect of physostigmine on memory in patients with Alzheimer's disease. Neurobiol Aging. 1982 Summer;3(2):105–110. doi: 10.1016/0197-4580(82)90004-5. [DOI] [PubMed] [Google Scholar]
  14. Muramoto O., Sugishita M., Ando K. Cholinergic system and constructional praxis: a further study of physostigmine in Alzheimer's disease. J Neurol Neurosurg Psychiatry. 1984 May;47(5):485–491. doi: 10.1136/jnnp.47.5.485. [DOI] [PMC free article] [PubMed] [Google Scholar]
  15. Perry E. K., Tomlinson B. E., Blessed G., Bergmann K., Gibson P. H., Perry R. H. Correlation of cholinergic abnormalities with senile plaques and mental test scores in senile dementia. Br Med J. 1978 Nov 25;2(6150):1457–1459. doi: 10.1136/bmj.2.6150.1457. [DOI] [PMC free article] [PubMed] [Google Scholar]
  16. Rosen W. G., Terry R. D., Fuld P. A., Katzman R., Peck A. Pathological verification of ischemic score in differentiation of dementias. Ann Neurol. 1980 May;7(5):486–488. doi: 10.1002/ana.410070516. [DOI] [PubMed] [Google Scholar]
  17. Roth M., Tym E., Mountjoy C. Q., Huppert F. A., Hendrie H., Verma S., Goddard R. CAMDEX. A standardised instrument for the diagnosis of mental disorder in the elderly with special reference to the early detection of dementia. Br J Psychiatry. 1986 Dec;149:698–709. doi: 10.1192/bjp.149.6.698. [DOI] [PubMed] [Google Scholar]
  18. Spinnler H., Della Sala S. The role of clinical neuropsychology in the neurological diagnosis of Alzheimer's disease. J Neurol. 1988 May;235(5):258–271. doi: 10.1007/BF00314172. [DOI] [PubMed] [Google Scholar]
  19. Summers W. K., Majovski L. V., Marsh G. M., Tachiki K., Kling A. Oral tetrahydroaminoacridine in long-term treatment of senile dementia, Alzheimer type. N Engl J Med. 1986 Nov 13;315(20):1241–1245. doi: 10.1056/NEJM198611133152001. [DOI] [PubMed] [Google Scholar]
  20. Wade J. P., Mirsen T. R., Hachinski V. C., Fisman M., Lau C., Merskey H. The clinical diagnosis of Alzheimer's disease. Arch Neurol. 1987 Jan;44(1):24–29. doi: 10.1001/archneur.1987.00520130016010. [DOI] [PubMed] [Google Scholar]

Articles from Journal of Neurology, Neurosurgery, and Psychiatry are provided here courtesy of BMJ Publishing Group

RESOURCES