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Outcome measures in clinical trials on medicinal products for the treatment of dementia: a European regulatory perspective
Broich K.. International psychogeriatrics, 2007-04-16
Topic: Risk, prevention and care in population studies
Plain-language summary
Based on efficacy and safety data, several drugs have been approved for symptomatic improvement of dementia of the Alzheimer type and one for the symptomatic improvement of dementia associated with Parkinson's disease. Depending on the disease stages (early versus late, mild to moderate to severe impairment) and disease entities, distinct assessment tools for cognitive, functional and global endpoints should be used or newly developed. The changes must be robust and clinically meaningful in favor of active treatment versus placebo. If a treatment claim for prevention of the emergence, slowing or stabilizing deterioration is strived for, it has to be shown that the treatment has an impact on the underlying neurobiology and pathophysiology of the process of dementia.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
APA 7th
Broich, K. (2007). Outcome measures in clinical trials on medicinal products for the treatment of dementia: a European regulatory perspective. International psychogeriatrics. https://doi.org/10.1017/s1041610207005273
Vancouver
Broich K. Outcome measures in clinical trials on medicinal products for the treatment of dementia: a European regulatory perspective. International psychogeriatrics. 2007. doi:10.1017/s1041610207005273. PMID: 17433121.
BibTeX
@article{broich2007-17433121,
author = {Broich, K.},
title = {{Outcome measures in clinical trials on medicinal products for the treatment of dementia: a European regulatory perspective}},
journal = {International psychogeriatrics},
year = {2007},
doi = {10.1017/s1041610207005273},
pmid = {17433121},
url = {https://doi.org/10.1017/s1041610207005273}
}
Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. Check the citation against the original before you use it.
Key findings
- Based on efficacy and safety data, several drugs have been approved for symptomatic improvement of dementia of the Alzheimer type and one for the symptomatic improvement of dementia associated with Parkinson's disease.
- Depending on the disease stages (early versus late, mild to moderate to severe impairment) and disease entities, distinct assessment tools for cognitive, functional and global endpoints should be used or newly developed.
- The changes must be robust and clinically meaningful in favor of active treatment versus placebo.
- If a treatment claim for prevention of the emergence, slowing or stabilizing deterioration is strived for, it has to be shown that the treatment has an impact on the underlying neurobiology and pathophysiology of the process of dementia.
Why it matters
This paper reviews regulatory requirements for measuring outcomes in dementia drug trials, not the results of a treatment study. It does not show whether any treatment works to treat, cure or prevent Alzheimer's disease.
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Study details
- Evidence strengthHigh
How this study scored 37/100
Published in a peer-reviewed journal. Scored zero for study design, sample size, effect reported, studied in people and randomized / blinded because the record does not state it.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (International psychogeriatrics) |
| Journal's citation record | 2 / 4 | International Psychogeriatrics: journal h-index 161 (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 | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 1 / 5 | 2007 — 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) |
| Randomized / blinded | 0 / 2 | No randomization or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | 3 / 7 | Cited 29 times (OpenAlex, 2026-10-10) |
| Citations per year | 1 / 5 | 1.4 citations a year over 21 year(s) since 2007 |
| Impact for its field and year | 3 / 6 | Cited 3.1× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 1 / 6 | Cited by 2 other studies in this library |
| Still being cited | 0 / 4 | Cited 0 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 2 / 4 | Last-listed author Karl Broich: h-index 42 (OpenAlex, whole career) |
| Institution's track record | 0 / 3 | Federal Institute for Drugs and Medical Devices: institution h-index 120 (OpenAlex) |
| Multicenter collaboration | 0 / 3 | OpenAlex lists 1 institution(s) in 1 country — scores zero (affiliation lists can be incomplete) |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 17433121) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Total | 37 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
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