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Cardiovascular and cerebrovascular events in the randomized, controlled Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT)
ADAPT Research Group.. PLoS clinical trials, 2006-11-17
Topic: Amyloid, tau and blood-test diagnosis
Objectives The Alzheimer's Disease Anti-inflammatory Prevention Trial (ADAPT) was designed to evaluate the conventional NSAID naproxen sodium and the selective COX-2 inhibitor celecoxib for primary prevention of Alzheimer's dementia (AD). On 17 December 2004, after the Adenoma Prevention with Celecoxib (APC) trial reported increased cardiovascular risks with celecoxib, the ADAPT Steering Committee suspended treatment and enrollment. This paper reports on cardiovascular and cerebrovascular events in ADAPT. Design ADAPT is a randomized, placebo-controlled, parallel chemoprevention trial with 1-46 mo of follow-up. Setting The trial was conducted at six field sites in the United States: Baltimore, Maryland; Boston, Massachusetts; Rochester, New York; Seattle, Washington; Sun City, Arizona; and Tampa, Florida. Participants The 2,528 participants were aged 70 y and older with a family history of AD. Interventions Study treatments were celecoxib (200 mg b.i.d.), naproxen sodium (220 mg b.i.d.), and placebo. Outcome measures Outcome measures were deaths, along with nonfatal myocardial infarction (MI), stroke, congestive heart failure (CHF), transient ischemic attack (TIA), and antihypertensive treatment recorded from structured interviews at scheduled intervals. Cox proportional hazards regression was used to analyze these events individually and in several composites. Results Counts (with 3-y incidence) of participants who experienced cardiovascular or cerebrovascular death, MI, stroke, CHF, or TIA in the celecoxib-, naproxen-, and placebo-treated groups were 28/717 (5.54%), 40/713 (8.25%), and 37/1070 (5.68%), respectively. This yielded a hazard ratio (95% confidence interval [CI]) for celecoxib of 1.10 (0.67-1.79) and for naproxen of 1.63 (1.04-2.55). Antihypertensive treatment was initiated in 160/440 (47.43%), 147/427 (45.00%), and 164/644 (34.08%). This yielded hazard ratios (CIs) of 1.56 for celecoxib (1.26-1.94) and 1.40 for naproxen (1.12-1.75). Conclusions For celecoxib, ADAPT data do not show the same level of risk as those of the APC trial. The data for naproxen, although not definitive, are suggestive of increased cardiovascular and cerebrovascular risk.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
APA 7th
ADAPT Research Group. (2006). Cardiovascular and cerebrovascular events in the randomized, controlled Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT). PLoS clinical trials. https://doi.org/10.1371/journal.pctr.0010033
Vancouver
ADAPT Research Group. Cardiovascular and cerebrovascular events in the randomized, controlled Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT). PLoS clinical trials. 2006. doi:10.1371/journal.pctr.0010033. PMID: 17111043.
BibTeX
@article{study2006-17111043,
author = {{ADAPT Research Group}},
title = {{Cardiovascular and cerebrovascular events in the randomized, controlled Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT)}},
journal = {PLoS clinical trials},
year = {2006},
doi = {10.1371/journal.pctr.0010033},
pmid = {17111043},
url = {https://doi.org/10.1371/journal.pctr.0010033}
}
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
- Results Counts (with 3-y incidence) of participants who experienced cardiovascular or cerebrovascular death, MI, stroke, CHF, or TIA in the celecoxib-, naproxen-, and placebo-treated groups were 28/717 (5.54%), 40/713 (8.25%), and 37/1070 (5.68%), respectively.
Why it matters
In this randomized prevention trial, cardiovascular or cerebrovascular events occurred in 5.54% of celecoxib-treated, 8.25% of naproxen-treated and 5.68% of placebo-treated participants, and treatment was suspended after another trial reported increased cardiovascular risk with celecoxib. The trial reports safety events rather than showing that these anti-inflammatory drugs prevent Alzheimer's dementia.
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Study details
- Participants2,528
- Effect size5.54%; 8.25%; 5.68%
- Evidence strengthHigh
How this study scored 55/100
Published in a peer-reviewed journal. Scored zero for study design because the record does not state it. We have no data on senior author's track record and institution's track record, so those were left out: it earned 51 of the 93 points we could judge it on, which is 55 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (PLoS clinical trials) |
| Journal's citation record | 0 / 4 | PLoS Clinical Trials: journal h-index 33 (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 | 2006 — older than 20 years, still counted |
| Sample size | 3 / 4 | 2,528 participants |
| Effect reported | 2 / 3 | Effect reported as a number, without an interval or test |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 1 / 2 | Randomised (as stated in the record) |
| Times cited | 5 / 7 | Cited 177 times (OpenAlex, 2026-10-10) |
| Citations per year | 3 / 5 | 8.0 citations a year over 22 year(s) since 2006 |
| Impact for its field and year | 4 / 6 | Cited 12.4× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 2 / 6 | Cited by 8 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 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multi-centre collaboration | 0 / 3 | OpenAlex lists 0 institution(s) in 0 countries — scores zero (affiliation lists can be incomplete) |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 17111043) |
| Free to read | 2 / 2 | Free to read |
| Points | 51 / 93 | Scored on 18 of 20 parts. We have no data for the rest, so they are left out: 51 of the 93 points we could judge it on is 55 out of 100. |
| Total | 55 / 100 | — |
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Read the original
- DOI: 10.1371/journal.pctr.0010033
- PubMed: 17111043
- Original source →
- Free full text: PLoS Clinical Trials →
Full text: free to read — OpenAlex lists this copy as free to read: the link above (checked 6 Feb 1020).
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