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Design and Rationale of the PACt-MD Randomized Clinical Trial: Prevention of Alzheimer's dementia with Cognitive remediation plus transcranial direct current stimulation in Mild cognitive impairment and Depression.

Design and Rationale of the PACt-MD Randomized Clinical Trial: Prevention of Alzheimer's dementia with Cognitive remediation plus transcranial direct current stimulation in Mild cognitive impairment and Depression.

Authors :
Rajji, Tarek K.
Bowie, Christopher R.
Herrmann, Nathan
Pollock, Bruce G.
Bikson, Marom
Blumberger, Daniel M.
Butters, Meryl A.
Daskalakis, Zafiris J.
Fischer, Corinne E.
Flint, Alastair J.
Golas, Angela C.
Graff-Guerrero, Ariel
Kumar, Sanjeev
Lourenco, Lillian
Mah, Linda
Ovaysikia, Shima
Thorpe, Kevin E.
Voineskos, Aristotle N.
Mulsant, Benoit H.
PACt-MD Study Group
Source :
Journal of Alzheimer's Disease. 2020, Vol. 76 Issue 2, p733-751. 19p.
Publication Year :
2020

Abstract

<bold>Background: </bold>By the time Alzheimer's disease and related disorders (ADRD) are diagnosed, efficacy of treatments is limited. Preventive interventions are urgently needed.<bold>Objective: </bold>To design a randomized controlled trial to assess a novel intervention that aims to prevent ADRD in high-risk groups.<bold>Methods: </bold>We report on the rationale and describe the design of a multisite randomized controlled trial that aims to prevent ADRD in older persons with: (1) mild cognitive impairment (MCI); (2) remitted major depressive disorder (MDD) without MCI; or (3) remitted MDD with MCI.<bold>Results: </bold>PACt-MD (Prevention of Alzheimer's dementia with Cognitive remediation plus transcranial direct current stimulation in Mild cognitive impairment and Depression) is a trial that randomized 375 older participants with MCI, MDD, or MCI + MDD to cognitive remediation (CR) plus transcranial direct current stimulation (tDCS) or sham-CR + sham-tDCS for 5 days/week for 8 weeks followed by boosters for 5 days/week once every 6 months until participants progress to MCI or ADRD, or the end of the study. Between boosters, participants are asked to train on CR daily. At baseline, end of 8 weeks, and yearly from baseline, participants undergo clinical, cognitive, and functional assessments. The primary aims are to compare the efficacy of CR + tDCS versus sham + sham in preventing: 1) long-term cognitive decline; and 2) incidence of ADRD or MCI. The secondary aim is to assess for cognitive improvement after the 8-week course. We will also explore the moderating and mediating effects of several biomarkers collected from the participants.<bold>Conclusion: </bold>PACt-MD is unique in combining brain stimulation and a psychosocial intervention to prevent ADRD. PACt-MD is also a platform for studying multi-domain biomarkers that will advance our understanding of the relationships among MCI, MDD, and ADRD. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
13872877
Volume :
76
Issue :
2
Database :
Academic Search Index
Journal :
Journal of Alzheimer's Disease
Publication Type :
Academic Journal
Accession number :
144715302
Full Text :
https://doi.org/10.3233/JAD-200141