Atomoxetine augmentation of cholinesterase inhibitor therapy in patients with Alzheimer disease: 6-month, randomized, double-blind, placebo-controlled, parallel-trial study

Mohs RC, Shiovitz TM, Tariot PN, Porsteinsson AP, Baker KD, Feldman PD.. The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry, 2009-09-01

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59/100

✓ Peer-reviewed alzhub usefulness score 59 out of 100. Treatments

Topic: Amyloid, tau and blood-test diagnosis

Plain-language summary

Objectives To examine the efficacy and tolerability of atomoxetine (ATX) in improving cognitive performance of patients with Alzheimer dementia. Design A randomized, double-blind, placebo (PLA)-controlled, parallel-groups study, starting with a 5-33-day screening and evaluation period, followed by a 6-month treatment period. Setting Eight independent or academic outpatient clinics in the United States. Participants Male or female patients, aged 55 years and older, with mild-to-moderate Alzheimer disease (Mini-Mental State Examination score between 10 and 26) at baseline. Intervention ATX (25-80 mg/day) or PLA for up to 6 months, added to ongoing cholinesterase-inhibitor therapy. Measurements Alzheimer Disease Assessment Scale-Cognitive Portion (ADAS-Cog, primary measure), Clinician's Interview-Based Impression of Change score at end point, Neuropsychiatric Inventory, and Alzheimer's Disease Cooperative Study Inventory-Activities of Daily Living Inventory total score, safety measures (secondary measures). Results Patients' (N = 92) scores on assessments of cognitive function, global clinical impression, and neuropsychiatric symptoms were not significantly different between treatment groups. Neither group showed significant changes from baseline on the primary measure of efficacy, the ADAS-Cog. The ATX group showed a significantly greater increase of heart rate, and the mean increase in diastolic blood pressure and decrease in weight differed significantly from the decrease in pressure and weight increase in the PLA group. No other clinically meaningful safety results were obtained. Conclusions Addition of ATX to ongoing cholinesterase-inhibitor therapy was generally well tolerated but did not significantly improve cognitive function.

What this study adds

Evidence grade: High

This is a trial of 92 participants. Adding atomoxetine to standard cholinesterase inhibitor therapy for 6 months did not improve cognition, global impression, or neuropsychiatric symptoms compared with placebo. This drug did not help treat Alzheimer's disease in this trial.

Taken from this record’s own fields, not from reading the paper. The grade is assigned from the abstract’s wording; what that means.

Cite this study APA, Vancouver, BibTeX · download .bib or .ris

APA 7th

Mohs, R. C., Shiovitz, T. M., Tariot, P. N., Porsteinsson, A. P., Baker, K. D., & Feldman, P. D. (2009). Atomoxetine augmentation of cholinesterase inhibitor therapy in patients with Alzheimer disease: 6-month, randomized, double-blind, placebo-controlled, parallel-trial study. The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry. https://doi.org/10.1097/jgp.0b013e3181aad585

Vancouver

Mohs RC, Shiovitz TM, Tariot PN, Porsteinsson AP, Baker KD, Feldman PD. Atomoxetine augmentation of cholinesterase inhibitor therapy in patients with Alzheimer disease: 6-month, randomized, double-blind, placebo-controlled, parallel-trial study. The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry. 2009. doi:10.1097/jgp.0b013e3181aad585. PMID: 19700948.

BibTeX

@article{mohs2009-19700948,
  author  = {Mohs, R. C. and Shiovitz, T. M. and Tariot, P. N. and Porsteinsson, A. P. and Baker, K. D. and Feldman, P. D.},
  title   = {{Atomoxetine augmentation of cholinesterase inhibitor therapy in patients with Alzheimer disease: 6-month, randomized, double-blind, placebo-controlled, parallel-trial study}},
  journal = {The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry},
  year    = {2009},
  doi     = {10.1097/jgp.0b013e3181aad585},
  pmid    = {19700948},
  url     = {https://doi.org/10.1097/jgp.0b013e3181aad585}
}

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How to read this study

Design: this is a trial. Participants are assigned to a treatment or a comparison, so the key questions are who was enrolled, whether the comparison group got a placebo or nothing, how long people were followed, and whether the result is on a measure that matters to patients or on a biomarker. Open-label and small trials can overstate benefit.
Size: the record lists 92 participants. Ask whether that is enough for the question, and who they were.
Effect: the record gives no effect size, so the summary above cannot say how large any difference was.

What the evidence grade means here

This page is graded high. alzhub.org assigns the grade automatically from keywords in the abstract, not from reading the paper. High means the abstract mentions a randomized design, a meta-analysis or a systematic review. It can add at most 5 of the 100 points in the study score, and it is a label about design, not a verdict on whether the findings are true.

New to reading papers? Six questions to ask of any Alzheimer’s study · how we score.

Key findings

Results Patients' (N = 92) scores on assessments of cognitive function, global clinical impression, and neuropsychiatric symptoms were not significantly different between treatment groups.
Neither group showed significant changes from baseline on the primary measure of efficacy, the ADAS-Cog.
The ATX group showed a significantly greater increase of heart rate, and the mean increase in diastolic blood pressure and decrease in weight differed significantly from the decrease in pressure and weight increase in the PLA group.
No other clinically meaningful safety results were obtained.
Conclusions Addition of ATX to ongoing cholinesterase-inhibitor therapy was generally well tolerated but did not significantly improve cognitive function.

Why it matters

Adding atomoxetine to standard cholinesterase inhibitor therapy for 6 months did not improve cognition, global impression, or neuropsychiatric symptoms compared with placebo. This drug did not help treat Alzheimer's disease in this trial.

New to this subject? Start with our plain-English guide: Treatments →

Study details

Participants92
Evidence strengthHigh

How this study scored 59/100

Published in a peer-reviewed journal, and it is a randomized controlled trial. Scored zero for effect reported because the record does not state it.

Component	Points	Why
Journal tier	7 / 10	Tier 3 — peer-reviewed journal (The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry)
Journal's citation record	2 / 4	American Journal of Geriatric Psychiatry: journal h-index 178 (OpenAlex, 2026-10-29)
Study design	11 / 12	A randomized controlled trial (from PubMed type “Randomized Controlled Trial”)
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	2009 — within 20 year(s) of the newest study here
Sample size	1 / 4	92 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)
Randomized / blinded	2 / 2	Randomized and blinded or placebo-controlled (as stated in the record)
Times cited	4 / 7	Cited 59 times (OpenAlex, 2026-10-10)
Citations per year	2 / 5	3.1 citations a year over 19 year(s) since 2009
Impact for its field and year	2 / 6	Cited 1.9× 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	1 / 4	Cited 11 times in 2024–2026 (2026 still in progress; OpenAlex)
Senior author's track record	2 / 4	Last-listed author Peter D. Feldman: h-index 29 (OpenAlex, whole career)
Institution's track record	1 / 3	University of Rochester Medicine: institution h-index 953 (OpenAlex)
Multicenter collaboration	2 / 3	OpenAlex lists 4 institution(s) in 1 country
Indexed in PubMed	2 / 2	Indexed in PubMed (PMID 19700948)
Free to read	0 / 2	Behind a paywall — scores zero
Total	59 / 100	—

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