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Efficacy and safety of galantamine in patients with mild to moderate Alzheimer's disease: multicentre randomised controlled trial. Galantamine International-1 Study Group
Wilcock GK, Lilienfeld S, Gaens E.. BMJ (Clinical research ed.), 2000-12-01
Topic: Amyloid, tau and blood-test diagnosis
Objective To evaluate the efficacy and safety of galantamine in the treatment of Alzheimer's disease. Design Randomised, double blind, parallel group, placebo controlled trial. Setting 86 outpatient clinics in Europe and Canada. Participants 653 patients with mild to moderate Alzheimer's disease. Intervention Patients randomly assigned to galantamine had their daily dose escalated over three to four weeks to maintenance doses of 24 or 32 mg. Main outcome measures Scores on the 11 item cognitive subscale of the Alzheimer's disease assessment scale, the clinician's interview based impression of change plus caregiver input, and the disability assessment for dementia scale. The effect of apolipoprotein E4 genotype on reponse to treatment was also assessed. Results At six months, patients who received galantamine had a significantly better outcome on the 11 item cognitive subscale of the Alzheimer's disease assessment scale than patients in the placebo group (mean treatment effect 2.9 points for lower dose and 3.1 for higher dose, intention to treat analysis, P Conclusion Galantamine is effective and well tolerated in Alzheimer's disease. As galantamine slowed the decline of functional ability as well as cognition, its effects are likely to be clinically relevant.
Key findings
- Results At six months, patients who received galantamine had a significantly better outcome on the 11 item cognitive subscale of the Alzheimer's disease assessment scale than patients in the placebo group (mean treatment effect 2.9 points for lower dose and 3.1 for higher dose, intention to treat analysis, P<0.001 for both doses).
Why it matters
In this six-month randomized trial of 653 patients, galantamine produced significantly better cognitive outcomes than placebo in mild to moderate Alzheimer's disease and also slowed decline in functional ability. This is a symptomatic treatment effect, not a cure or prevention.
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Study details
- Participants653
- Evidence strengthHigh
How this study scored 64/100
Published in a leading specialty journal. Scored zero for study design and effect reported because the record does not state it. We have no data on senior author's track record, so that was left out: it earned 61 of the 96 points we could judge it on, which is 64 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 9 / 10 | Tier 2 — leading specialty journal (BMJ (Clinical research ed.)) |
| Journal's citation record | 4 / 4 | BMJ: journal h-index 608 (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 | 2000 — older than 20 years, still counted |
| Sample size | 2 / 4 | 653 participants |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 2 / 2 | Randomised and blinded or placebo-controlled (as stated in the record) |
| Times cited | 6 / 7 | Cited 627 times (OpenAlex, 2026-10-10) |
| Citations per year | 4 / 5 | 22.4 citations a year over 28 year(s) since 2000 |
| Impact for its field and year | 5 / 6 | Cited 23.4× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 3 / 6 | Cited by 23 other studies in this library |
| Still being cited | 2 / 4 | Cited 43 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | — / 4 | OpenAlex's profile for last-listed author E. Gaens holds only 2 work(s), too few to judge a track record — left out of this score |
| Institution's track record | 1 / 3 | University of Bristol: institution h-index 1,260 (OpenAlex) |
| Multi-centre collaboration | 2 / 3 | PubMed indexes it as a multicentre study |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 11110737) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Points | 61 / 96 | Scored on 19 of 20 parts. We have no data for the rest, so they are left out: 61 of the 96 points we could judge it on is 64 out of 100. |
| Total | 64 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
Full text: free to read — OpenAlex lists this copy as free to read: the link above (checked 6 Feb 1020).
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
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.
APA 7th
Wilcock, G. K., Lilienfeld, S., & Gaens, E. (2000). Efficacy and safety of galantamine in patients with mild to moderate Alzheimer's disease: multicentre randomised controlled trial. Galantamine International-1 Study Group. BMJ (Clinical research ed.). https://doi.org/10.1136/bmj.321.7274.1445
Vancouver
Wilcock GK, Lilienfeld S, Gaens E. Efficacy and safety of galantamine in patients with mild to moderate Alzheimer's disease: multicentre randomised controlled trial. Galantamine International-1 Study Group. BMJ (Clinical research ed.). 2000. doi:10.1136/bmj.321.7274.1445. PMID: 11110737.
BibTeX
@article{wilcock2000-11110737,
author = {Wilcock, G. K. and Lilienfeld, S. and Gaens, E.},
title = {{Efficacy and safety of galantamine in patients with mild to moderate Alzheimer's disease: multicentre randomised controlled trial. Galantamine International-1 Study Group}},
journal = {BMJ (Clinical research ed.)},
year = {2000},
doi = {10.1136/bmj.321.7274.1445},
pmid = {11110737},
url = {https://doi.org/10.1136/bmj.321.7274.1445}
}
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