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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.
- 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]
- Subjects :
- *TRANSCRANIAL direct current stimulation
*ALZHEIMER'S disease
*MILD cognitive impairment
*DISEASES
*BRAIN stimulation
*CLINICAL trials
*ALZHEIMER'S disease prevention
*DEMENTIA prevention
*RESEARCH
*RESEARCH methodology
*MEDICAL cooperation
*EVALUATION research
*COMPARATIVE studies
*MENTAL depression
*DEMENTIA
*COMBINED modality therapy
Subjects
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