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Atomoxetine augmentation of cholinesterase inhibitor therapy in patients with Alzheimer disease: 6-month, randomized, double-blind, placebo-controlled, parallel-trial study.
Am J Geriatr Psychiatry. 2009 Sep; 17(9):752-9.AJ

Abstract

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.

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Authors+Show Affiliations

Mohs RC
Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285, USA. mohsri@lilly.com
Shiovitz TM
No affiliation info available
Tariot PN
No affiliation info available
Porsteinsson AP
No affiliation info available
Baker KD
No affiliation info available
Feldman PD
No affiliation info available

MeSH

Adrenergic Uptake InhibitorsAgedAged, 80 and overAlzheimer DiseaseAtomoxetine HydrochlorideCholinesterase InhibitorsCognitionCognition DisordersDouble-Blind MethodFemaleHumansMaleMiddle AgedNeuropsychological TestsPropylaminesTreatment Outcome

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19700948

Citation

Mohs, Richard C., et al. "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, vol. 17, no. 9, 2009, pp. 752-9.
Mohs RC, Shiovitz TM, Tariot PN, et al. Atomoxetine augmentation of cholinesterase inhibitor therapy in patients with Alzheimer disease: 6-month, randomized, double-blind, placebo-controlled, parallel-trial study. Am J Geriatr Psychiatry. 2009;17(9):752-9.
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, 17(9), 752-9. https://doi.org/10.1097/JGP.0b013e3181aad585
Mohs RC, et al. Atomoxetine Augmentation of Cholinesterase Inhibitor Therapy in Patients With Alzheimer Disease: 6-month, Randomized, Double-blind, Placebo-controlled, Parallel-trial Study. Am J Geriatr Psychiatry. 2009;17(9):752-9. PubMed PMID: 19700948.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Atomoxetine augmentation of cholinesterase inhibitor therapy in patients with Alzheimer disease: 6-month, randomized, double-blind, placebo-controlled, parallel-trial study. AU - Mohs,Richard C, AU - Shiovitz,Thomas M, AU - Tariot,Pierre N, AU - Porsteinsson,Anton P, AU - Baker,Kurt D, AU - Feldman,Peter D, PY - 2009/8/25/entrez PY - 2009/8/25/pubmed PY - 2009/10/21/medline SP - 752 EP - 9 JF - The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry JO - Am J Geriatr Psychiatry VL - 17 IS - 9 N2 - 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. SN - 1545-7214 UR - https://www.unboundmedicine.com/medline/citation/19700948/Atomoxetine_augmentation_of_cholinesterase_inhibitor_therapy_in_patients_with_Alzheimer_disease:_6_month_randomized_double_blind_placebo_controlled_parallel_trial_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/00019442-200909000-00006 DB - PRIME DP - Unbound Medicine ER -