Study Summary
This trial is studying a potential treatment for Alzheimer's disease that involves training people to change their brain function.
Eligible Conditions
- Mild Cognitive Impairment
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: From baseline to 12 weeks of treatment
Week 12
Change in Gamma Band Response
Change in Working Memory accuracy
From baseline to 4weeks post end of study
Durability of Change in Working Memory accuracy
Durability of Gamma Band Response
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Active Treatment
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
112 Total Participants · 2 Treatment Groups
Primary Treatment: Neurofeedback · Has Placebo Group · N/A
Active Treatment
Behavioral
Experimental Group · 1 Intervention: Neurofeedback · Intervention Types: BehavioralPlacebo
Other
ShamComparator Group · 1 Intervention: Placebo · Intervention Types: OtherTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neurofeedback
2019
Completed Phase 3
~1010
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to 12 weeks of treatment
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,028 Previous Clinical Trials
1,805,909 Total Patients Enrolled
Eligibility Criteria
Age 50 - 85 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The ability to live independently is a crucial skill for everyone
I can read and write in English.
able to take part in the decision-making process about whether to agree to a medical procedure, and giving voluntary consent.
Meet certain criteria that suggest that someone has mild cognitive impairment.
References
- Döhnel, Katrin, Monika Sommer, Bernd Ibach, Christoph Rothmayr, Jörg Meinhardt, and Göran Hajak. 2008. “Neural Correlates of Emotional Working Memory in Patients with Mild Cognitive Impairment”. Neuropsychologia. Elsevier BV. doi:10.1016/j.neuropsychologia.2007.08.012.
- Uhlhaas, Peter J., and Wolf Singer. 2006. “Neural Synchrony in Brain Disorders: Relevance for Cognitive Dysfunctions and Pathophysiology”. Neuron. Elsevier BV. doi:10.1016/j.neuron.2006.09.020.
- Diamond, Adele. 2013. “Executive Functions”. Annual Review of Psychology. Annual Reviews. doi:10.1146/annurev-psych-113011-143750.
- Stam, Cornelis J., Anne Marie van Cappellen van Walsum, Yolande A. L. Pijnenburg, Henk W. Berendse, Jan C. de Munck, Philip Scheltens, and Bob W. van Dijk. 2002. “Generalized Synchronization of MEG Recordings in Alzheimer’s Disease: Evidence for Involvement of the Gamma Band”. Journal of Clinical Neurophysiology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00004691-200212000-00010.
- LEUCHTER, ANDREW F., THOMAS F. NEWTON, IAN A. COOK, DONALD O. WALTER, SUSAN ROSENBERG-THOMPSON, and PETER A. LACHENBRUCH. 1992. “Changes in Brain Functional Connectivity in Alzheimer-type and Multi-infarct Dementia”. Brain. Oxford University Press (OUP). doi:10.1093/brain/115.5.1543.
- Diamond, Adele. 2013. “Executive Functions”. Annual Review of Psychology. Annual Reviews. doi:10.1146/annurev-psych-113011-143750.
- Stam CJ, van Cappellen van Walsum AM, Pijnenburg YA, Berendse HW, de Munck JC, Scheltens P, van Dijk BW. Generalized synchronization of MEG recordings in Alzheimer's Disease: evidence for involvement of the gamma band. J Clin Neurophysiol. 2002 Dec;19(6):562-74. doi: 10.1097/00004691-200212000-00010.
- Leuchter AF, Newton TF, Cook IA, Walter DO, Rosenberg-Thompson S, Lachenbruch PA. Changes in brain functional connectivity in Alzheimer-type and multi-infarct dementia. Brain. 1992 Oct;115 ( Pt 5):1543-61. doi: 10.1093/brain/115.5.1543.
- Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27.
- Uhlhaas PJ, Singer W. Neural synchrony in brain disorders: relevance for cognitive dysfunctions and pathophysiology. Neuron. 2006 Oct 5;52(1):155-68. doi: 10.1016/j.neuron.2006.09.020.
- Dohnel K, Sommer M, Ibach B, Rothmayr C, Meinhardt J, Hajak G. Neural correlates of emotional working memory in patients with mild cognitive impairment. Neuropsychologia. 2008 Jan 15;46(1):37-48. doi: 10.1016/j.neuropsychologia.2007.08.012. Epub 2007 Aug 23.
- Fiza Singh 2021. "Neurofeedback to Improve Working Memory in Mild Cognitive Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04566900.
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