Methodological Issues in Primary Prevention Trials for Neurodegenerative Dementia

S. Andrieu, N. Coley, P. Aisen, M.C. Carrillo, S. DeKosky, J. Durga, H. Fillit, G.B. Frisoni, L. Froelich, S. Gauthier, R. Jones, L. Jonsson, Z. Khachaturian, J.C. Morris, J.M. Orgogozo, P.J. Ousset, P. Robert, E. Salmon, C. Sampaio, F. Verhey & 2 others G. Wilcock, B. Vellas

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

The prevention of neurodegenerative dementias, such as Alzheimer's disease, is a public health priority. Due to the large numbers of affected patients, even interventions bringing about a relatively small delay in disease onset could have large public health effects. Randomized controlled trials (RCTs) are required to demonstrate the effectiveness of preventive interventions, but such trials raise specific methodological questions because they are new in the field of neurodegenerative diseases, and require large numbers of elderly subjects and lengthy follow-up periods. We performed a literature search to identify primary prevention RCTs for neurodegenerative dementia. The methodology of the trials was summarized and discussed during two expert meetings. Overall, 39 trials were identified that assessed dementia incidence or cognitive decline as a primary or secondary study outcome. Age was the most common selection criteria for target populations. Follow-up periods ranged from one month to nine years and were longest in studies measuring dementia incidence as an outcome. Results of RCTs have so far been generally negative and conflicting with those of observational studies, perhaps due to methodological issues. Future trials must therefore carefully consider the target population, outcomes and duration of follow-up to be used, and should assess the problem of attrition.
Original languageEnglish
Pages (from-to)235-270
JournalJournal of Alzheimers Disease
Volume16
Issue number2
DOIs
Publication statusPublished - 2009

Fingerprint

Primary Prevention
Dementia
Randomized Controlled Trials
Health Services Needs and Demand
Public Health
Health Priorities
Incidence
Neurodegenerative Diseases
Patient Selection
Observational Studies
Alzheimer Disease
Outcome Assessment (Health Care)

Keywords

  • mild cognitive impairment
  • randomized controlled-trial
  • placebo-controlled trial
  • health initiative memory
  • quality-of-life
  • mrc/bhf heart protection
  • population-based cohort
  • vascular risk-factors
  • mini-mental state
  • alzheimers-disease

Cite this

Andrieu, S., Coley, N., Aisen, P., Carrillo, M. C., DeKosky, S., Durga, J., ... Vellas, B. (2009). Methodological Issues in Primary Prevention Trials for Neurodegenerative Dementia. Journal of Alzheimers Disease, 16(2), 235-270. https://doi.org/10.3233/JAD-2009-0971
Andrieu, S. ; Coley, N. ; Aisen, P. ; Carrillo, M.C. ; DeKosky, S. ; Durga, J. ; Fillit, H. ; Frisoni, G.B. ; Froelich, L. ; Gauthier, S. ; Jones, R. ; Jonsson, L. ; Khachaturian, Z. ; Morris, J.C. ; Orgogozo, J.M. ; Ousset, P.J. ; Robert, P. ; Salmon, E. ; Sampaio, C. ; Verhey, F. ; Wilcock, G. ; Vellas, B. / Methodological Issues in Primary Prevention Trials for Neurodegenerative Dementia. In: Journal of Alzheimers Disease. 2009 ; Vol. 16, No. 2. pp. 235-270.
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Andrieu, S, Coley, N, Aisen, P, Carrillo, MC, DeKosky, S, Durga, J, Fillit, H, Frisoni, GB, Froelich, L, Gauthier, S, Jones, R, Jonsson, L, Khachaturian, Z, Morris, JC, Orgogozo, JM, Ousset, PJ, Robert, P, Salmon, E, Sampaio, C, Verhey, F, Wilcock, G & Vellas, B 2009, 'Methodological Issues in Primary Prevention Trials for Neurodegenerative Dementia', Journal of Alzheimers Disease, vol. 16, no. 2, pp. 235-270. https://doi.org/10.3233/JAD-2009-0971

Methodological Issues in Primary Prevention Trials for Neurodegenerative Dementia. / Andrieu, S.; Coley, N.; Aisen, P.; Carrillo, M.C.; DeKosky, S.; Durga, J.; Fillit, H.; Frisoni, G.B.; Froelich, L.; Gauthier, S.; Jones, R.; Jonsson, L.; Khachaturian, Z.; Morris, J.C.; Orgogozo, J.M.; Ousset, P.J.; Robert, P.; Salmon, E.; Sampaio, C.; Verhey, F.; Wilcock, G.; Vellas, B.

In: Journal of Alzheimers Disease, Vol. 16, No. 2, 2009, p. 235-270.

Research output: Contribution to journalArticleAcademicpeer-review

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AU - Andrieu, S.

AU - Coley, N.

AU - Aisen, P.

AU - Carrillo, M.C.

AU - DeKosky, S.

AU - Durga, J.

AU - Fillit, H.

AU - Frisoni, G.B.

AU - Froelich, L.

AU - Gauthier, S.

AU - Jones, R.

AU - Jonsson, L.

AU - Khachaturian, Z.

AU - Morris, J.C.

AU - Orgogozo, J.M.

AU - Ousset, P.J.

AU - Robert, P.

AU - Salmon, E.

AU - Sampaio, C.

AU - Verhey, F.

AU - Wilcock, G.

AU - Vellas, B.

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PY - 2009

Y1 - 2009

N2 - The prevention of neurodegenerative dementias, such as Alzheimer's disease, is a public health priority. Due to the large numbers of affected patients, even interventions bringing about a relatively small delay in disease onset could have large public health effects. Randomized controlled trials (RCTs) are required to demonstrate the effectiveness of preventive interventions, but such trials raise specific methodological questions because they are new in the field of neurodegenerative diseases, and require large numbers of elderly subjects and lengthy follow-up periods. We performed a literature search to identify primary prevention RCTs for neurodegenerative dementia. The methodology of the trials was summarized and discussed during two expert meetings. Overall, 39 trials were identified that assessed dementia incidence or cognitive decline as a primary or secondary study outcome. Age was the most common selection criteria for target populations. Follow-up periods ranged from one month to nine years and were longest in studies measuring dementia incidence as an outcome. Results of RCTs have so far been generally negative and conflicting with those of observational studies, perhaps due to methodological issues. Future trials must therefore carefully consider the target population, outcomes and duration of follow-up to be used, and should assess the problem of attrition.

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KW - mild cognitive impairment

KW - randomized controlled-trial

KW - placebo-controlled trial

KW - health initiative memory

KW - quality-of-life

KW - mrc/bhf heart protection

KW - population-based cohort

KW - vascular risk-factors

KW - mini-mental state

KW - alzheimers-disease

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