Evidence map›Paper›PMID 27756421›Full record

Trial reportAlzheimer's research & therapy2016

ABT-126 monotherapy in mild-to-moderate Alzheimer's dementia: randomized double-blind, placebo and active controlled adaptive trial and open-label extension.

Laura M Gault, Robert A Lenz, Craig W Ritchie, Andreas Meier, Ahmed A Othman, Qi Tang, Scott Berry, Yili Pritchett, Weining Z Robieson

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Alzheimer's research & therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
4.3field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01527916 phase2completednot on this map

A Randomized, Double-Blind, Placebo and Active-Controlled Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease

TypeinterventionalSponsorAbbVie (prior sponsor, Abbott)Ran2012 to 2013Enrolled438ConditionsAlzheimer's DiseaseArmsplacebo, donepezil, ABT-126
NCT01676935 phase2terminatednot on this map

Long-Term Safety and Tolerability of ABT-126 in Subjects With Mild-to-Moderate Alzheimer's Disease: An Open-Label Extension Study for Subjects Completing Study M10-985

TypeinterventionalSponsorAbbVie (prior sponsor, Abbott)Ran2012 to 2014Enrolled349ConditionsAlzheimer's DiseaseArmsABT-126
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 39 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. ABBV-552 in patients with mild Alzheimer's disease: a randomized phase IIb trial.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025
    Trial
  4. Subcutaneous application ofFrontiers in public health · 2026
    Observational
  5. Review
  6. Article
  7. Review
  8. Review
  9. Article
  10. Review
  11. Nicotinic Acetylcholine Receptor Agonists for the Treatment of Alzheimer's Dementia: An Update.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2019
    Review
  12. Nicotinic Acetylcholine Receptor Ligands, Cognitive Function, and Preclinical Approaches to Drug Discovery.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2019
    Review
  13. Article
  14. Review
  15. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 3 countries.

Laura M GaultAbbVie, Inc., 1 North Waukegan Rd, North Chicago, IL, 60064, USA. laura.gault@abbvie.com.
Robert A LenzAbbVie, Inc., 1 North Waukegan Rd, North Chicago, IL, 60064, USA.
Craig W RitchieUniversity of Edinburgh, Edinburgh, UK.
Andreas MeierPresent Address: Pfizer, Cambridge, MA, USA.
Ahmed A OthmanAbbVie, Inc., 1 North Waukegan Rd, North Chicago, IL, 60064, USA.
Qi TangAbbVie, Inc., 1 North Waukegan Rd, North Chicago, IL, 60064, USA.
Scott BerryBerry Consultants, LLC, Austin, TX, USA.
Yili PritchettAbbVie, Inc., 1 North Waukegan Rd, North Chicago, IL, 60064, USA.
Weining Z RobiesonAbbVie, Inc., 1 North Waukegan Rd, North Chicago, IL, 60064, USA.
AbbVie (United States) · USBerry & Associates (United States) · USPfizer (United States) · USUniversity of Edinburgh · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundResults from a phase 2a study indicated that treatment with the novel α7 nicotinic acetylcholine receptor agonist ABT-126 25 mg once daily (QD) was associated with a trend for improvement in cognition in subjects with mild-to-moderate Alzheimer's dementia (AD). A phase 2b program was designed to evaluate a broader dose range of ABT-126 as monotherapy in subjects with mild-to-moderate AD. The program consisted of a double-blind, placebo and active controlled study of ABT-126 (dose range 25-75 mg) and an open-label extension study (75 mg).

methodsThe randomized double-blind study enrolled 438 subjects (Mini-Mental Status Examination score of 10-24, inclusive) not currently taking acetylcholinesterase inhibitors or memantine. Subjects received 24 weeks of ABT-126 25 mg QD (n = 77), ABT-126 50 mg QD (n = 108), ABT-126 75 mg QD (n = 73), donepezil 10 mg QD (n = 76), or placebo (n = 104). The primary endpoint was the change from baseline to week 24 in the 11-item Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) total score. Subjects completing the double-blind study could enroll in the 28-week open-label extension study. Adverse events (AEs) and other safety parameters were monitored in both studies.

resultsA total of 367 patients (83.8 %) completed the double-blind study and 349 (79.7 %) entered the open-label study. Compared with placebo, donepezil significantly improved ADAS-Cog 11-item total scores from baseline to week 24 (-2.29 ± 0.95; one-sided P = 0.008). No ABT-126 dose demonstrated a statistically significant improvement vs placebo at week 24 in the ADAS-Cog total score: ABT-126 25 mg, -0.47 ± 0.94 (P = 0.309); ABT-126 50 mg, -0.87 ± 0.85 (P = 0.153); and ABT-126 75 mg, -1.08 ± 0.94 (P = 0.127). Rates of serious AEs and discontinuations due to AEs were similar across treatment groups. The most frequently reported AEs in both studies were constipation, fall, and headache. No clinically meaningful changes were observed in other parameters.

conclusionsIn the double-blind trial, donepezil significantly improved ADAS-Cog scores but no statistically significant improvement was seen with any ABT-126 dose. ABT-126 had an acceptable safety profile in subjects with mild-to-moderate AD in both studies.

trial registrationClinicalTrials.gov NCT01527916 , Registered 3 February 2012 (randomized trial). ClinicalTrials.gov NCT01676935 . Registered 29 August 2012 (open-label extension study).

Indexed as

AgedAged, 80 and overAlzheimer DiseaseAnalysis of VarianceCholinergic AgonistsCholinesterase InhibitorsCognition DisordersDonepezilDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansIndansMaleMental Status ScheduleMiddle AgedABT-126Cholinergic AgonistsCholinesterase InhibitorsDonepezilIndansPiperidinesQuinuclidinesThiadiazolesABT-126Adaptive designAlzheimer’s dementia/drug therapyAlzheimer’s diseaseAssessment of cognitive disorders/dementiaNicotinic agonistsRandomized controlled trial

Identifiers

PMID27756421
PMCPMC5067903
OpenAlexW2534984889

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.