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Enrichment through biomarkers in clinical trials of Alzheimer's drugs in patients with mild cognitive impairment
Lorenzi M, Donohue M, Paternicò D, Scarpazza C, Ostrowitzki S, Blin O, Irving E, Frisoni GB et al.. Neurobiology of aging, 2010-06-11
Topic: Amyloid, tau and blood-test diagnosis
Clinical trials of disease modifying drugs for Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) might benefit from enrichment with true AD cases. Four hundred five MCI patients (143 converters and 262 nonconverters to AD within 2 years) of the Alzheimer's disease Neuroimaging Initiative (ADNI) were used. Markers for enrichment were hippocampal atrophy on magnetic resonance (MRI), temporoparietal hypometabolism on FDG PET, cerebrospinal fluid (CSF) biomarkers (Abeta42, tau, and phospho-tau), and cortical amyloid deposition (11C-PIB positron emission tomography (PET)).
Key findings
- Four hundred five MCI patients (143 converters and 262 nonconverters to AD within 2 years) of the Alzheimer's disease Neuroimaging Initiative (ADNI) were used.
- Markers for enrichment were hippocampal atrophy on magnetic resonance (MRI), temporoparietal hypometabolism on FDG PET, cerebrospinal fluid (CSF) biomarkers (Abeta42, tau, and phospho-tau), and cortical amyloid deposition (11C-PIB positron emission tomography (PET)).
- Two separate enrichment strategies were tested to A) maximize the proportion of MCI converters screened in, and B) minimize the proportion of MCI converters screened out.
- Based on strategy A, when compared with no enrichment and ADAS-Cog as an outcome measure (sample size of 834), enrichment with 18F-FDG PET and hippocampal volume lowered samples size to 260 and 277 cases per arm, but at the cost of screening out 1,597 and 434 cases per arm.
Why it matters
This study tested whether using biomarkers could improve clinical trials of Alzheimer's drugs by selecting patients with mild cognitive impairment who truly have Alzheimer's disease. It is about trial design and does not show that any treatment works.
Study details
- Evidence strengthLow
How this study scored 45/100
Published in a peer-reviewed journal. Scored zero for study design, sample size, effect reported, studied in people and randomised / blinded because the record does not state it.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Neurobiology of aging) |
| Journal's citation record | 3 / 4 | Neurobiology of Aging: journal h-index 263 (OpenAlex, 2026-10-29) |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (not stated in the record — scored 0) |
| Strength of evidence | 1 / 5 | Rated “low” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 1 / 5 | 2010 — within 20 year(s) of the newest study here |
| Sample size | 0 / 4 | Participant count not stated — scores zero (not stated in the record — scored 0) |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 0 / 3 | Not stated whether this was studied in people — scores zero (not stated in the record — scored 0) |
| Randomised / blinded | 0 / 2 | No randomisation or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | 4 / 7 | Cited 54 times (OpenAlex, 2026-10-10) |
| Citations per year | 2 / 5 | 3.0 citations a year over 18 year(s) since 2010 |
| Impact for its field and year | 3 / 6 | Cited 5.0× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 2 / 6 | Cited by 9 other studies in this library |
| Still being cited | 1 / 4 | Cited 3 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 4 / 4 | Last-listed author Giovanni Battista Frisoni: h-index 120 (OpenAlex, whole career) |
| Institution's track record | 3 / 3 | Centre National de la Recherche Scientifique: institution h-index 2,511 (OpenAlex) |
| Multi-centre collaboration | 2 / 3 | OpenAlex lists 7 institution(s) in 5 countries |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 20541287) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Total | 45 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
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Cite this study APA, Vancouver, BibTeX · download .bib or .ris
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APA 7th
Lorenzi, M., Donohue, M., Paternicò, D., Scarpazza, C., Ostrowitzki, S., Blin, O., et al. (2010). Enrichment through biomarkers in clinical trials of Alzheimer's drugs in patients with mild cognitive impairment. Neurobiology of aging. https://doi.org/10.1016/j.neurobiolaging.2010.04.036
Vancouver
Lorenzi M, Donohue M, Paternicò D, Scarpazza C, Ostrowitzki S, Blin O, et al. Enrichment through biomarkers in clinical trials of Alzheimer's drugs in patients with mild cognitive impairment. Neurobiology of aging. 2010. doi:10.1016/j.neurobiolaging.2010.04.036. PMID: 20541287.
BibTeX
@article{lorenzi2010-20541287,
author = {Lorenzi, M. and Donohue, M. and Paternicò, D. and Scarpazza, C. and Ostrowitzki, S. and Blin, O. and Irving, E. and Frisoni, G. B. and others},
title = {{Enrichment through biomarkers in clinical trials of Alzheimer's drugs in patients with mild cognitive impairment}},
journal = {Neurobiology of aging},
year = {2010},
doi = {10.1016/j.neurobiolaging.2010.04.036},
pmid = {20541287},
url = {https://doi.org/10.1016/j.neurobiolaging.2010.04.036}
}
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