Alzheimer Disease Clinical Trial
— SMARTOfficial title:
Precision Medicine in Alzheimer's Disease: A SMART Trial of Adaptive Exercises and Their Mechanisms of Action Using AT(N) Biomarkers to Optimize Aerobic-Fitness Responses (The FIT-AD SMART Trial)
The goal of this clinical trial is to test 6 months of aerobic exercise in older adults who are 65 years or older and have mild cognitive impairment (MCI) or probable/possible mild Alzheimer's Disease. The main questions it aims to answer are: - test the effects of aerobic exercise on aerobic fitness, white matter hyperintensity (WMH) volume, and patient-centered outcomes; - identify the best exercise to improve aerobic fitness and reduce non-responses over 6 months; and - examines the mechanisms of aerobic exercise's action on memory in older adults with early AD. Participants will receive 6 months of supervised exercise, undergo cognitive data collection and exercise testing 5 times over a year span, have an MRI brain scan 3 times over a one-year span, and have monthly follow-up discussions on health and wellness.
Status | Recruiting |
Enrollment | 216 |
Est. completion date | June 30, 2028 |
Est. primary completion date | April 1, 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: Participants: - Clinical diagnosis of MCI or probable and possible mild AD dementia according to 2011 Alzheimer's association-NIA criteria. - Community-dwelling, e.g., homes and assisted living - Age 65 years and older - Medical clearance from PCP or cardiovascular provider - Have a qualified study partner - Agree to the blood draws - Verified MRI safety Study Partner: - Age 18 or older - Contact with participant = 2 times per week for = 6 months - Know the participant's memory status and ability to perform activities of daily living - Consent to participant Exclusion Criteria: Participants - Resting HR = 50 or = 100 beats/min after 5-minutes of quiet resting - American College of Sports Medicine contraindications to exercise - New, unevaluated symptoms or diseases a healthcare provider has not evaluated - Abnormal cardiac condition uncovered during VO2peak testing - Enrollment in another intervention that aims at improving cognition - Moderate to strenuous exercise =150 minutes a week in the previous 6 months - = 2 anti-depression medications, or poorly managed or unstable depression - Poorly managed or unstable anxiety Study partners: - none |
Country | Name | City | State |
---|---|---|---|
United States | Arizona State University | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Arizona State University | Banner Alzheimer's Institute |
United States,
Almirall D, Nahum-Shani I, Sherwood NE, Murphy SA. Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research. Transl Behav Med. 2014 Sep;4(3):260-74. doi: 10.1007/s13142-014-0265-0. — View Citation
Arcoverde C, Deslandes A, Moraes H, Almeida C, Araujo NB, Vasques PE, Silveira H, Laks J. Treadmill training as an augmentation treatment for Alzheimer's disease: a pilot randomized controlled study. Arq Neuropsiquiatr. 2014 Mar;72(3):190-6. doi: 10.1590/0004-282X20130231. — View Citation
Association As. 2021 Alzheimer's disease facts and figures. Accessed April 21, 2021, 2021. https://www.alz.org/media/Documents/alzheimers-facts-and-figures-infographic.pdf
Baker LD, Frank LL, Foster-Schubert K, Green PS, Wilkinson CW, McTiernan A, Plymate SR, Fishel MA, Watson GS, Cholerton BA, Duncan GE, Mehta PD, Craft S. Effects of aerobic exercise on mild cognitive impairment: a controlled trial. Arch Neurol. 2010 Jan;67(1):71-9. doi: 10.1001/archneurol.2009.307. — View Citation
Bossers WJ, van der Woude LH, Boersma F, Hortobagyi T, Scherder EJ, van Heuvelen MJ. A 9-Week Aerobic and Strength Training Program Improves Cognitive and Motor Function in Patients with Dementia: A Randomized, Controlled Trial. Am J Geriatr Psychiatry. 2015 Nov;23(11):1106-16. doi: 10.1016/j.jagp.2014.12.191. Epub 2015 Jan 3. — View Citation
Bossers WJ, van der Woude LH, Boersma F, Hortobagyi T, Scherder EJ, van Heuvelen MJ. Comparison of Effect of Two Exercise Programs on Activities of Daily Living in Individuals with Dementia: A 9-Week Randomized, Controlled Trial. J Am Geriatr Soc. 2016 Jun;64(6):1258-66. doi: 10.1111/jgs.14160. — View Citation
Bouchard C, Rankinen T. Individual differences in response to regular physical activity. Med Sci Sports Exerc. 2001 Jun;33(6 Suppl):S446-51; discussion S452-3. doi: 10.1097/00005768-200106001-00013. — View Citation
Burns JM, Johnson DK, Watts A, Swerdlow RH, Brooks WM. Reduced lean mass in early Alzheimer disease and its association with brain atrophy. Arch Neurol. 2010 Apr;67(4):428-33. doi: 10.1001/archneurol.2010.38. — View Citation
Cancela JM, Ayan C, Varela S, Seijo M. Effects of a long-term aerobic exercise intervention on institutionalized patients with dementia. J Sci Med Sport. 2016 Apr;19(4):293-8. doi: 10.1016/j.jsams.2015.05.007. Epub 2015 Jun 4. — View Citation
Colcombe S, Kramer AF. Fitness effects on the cognitive function of older adults: a meta-analytic study. Psychol Sci. 2003 Mar;14(2):125-30. doi: 10.1111/1467-9280.t01-1-01430. — View Citation
Fleiner T, Leucht S, Forstl H, Zijlstra W, Haussermann P. Effects of Short-Term Exercise Interventions on Behavioral and Psychological Symptoms in Patients with Dementia: A Systematic Review. J Alzheimers Dis. 2017;55(4):1583-1594. doi: 10.3233/JAD-160683. — View Citation
Forbes D, Forbes SC, Blake CM, Thiessen EJ, Forbes S. Exercise programs for people with dementia. Cochrane Database Syst Rev. 2015 Apr 15;2015(4):CD006489. doi: 10.1002/14651858.CD006489.pub4. — View Citation
Gomes-Neto M, Duraes AR, Conceicao LSR, Roever L, Silva CM, Alves IGN, Ellingsen O, Carvalho VO. Effect of combined aerobic and resistance training on peak oxygen consumption, muscle strength and health-related quality of life in patients with heart failure with reduced left ventricular ejection fraction: a systematic review and meta-analysis. Int J Cardiol. 2019 Oct 15;293:165-175. doi: 10.1016/j.ijcard.2019.02.050. Epub 2019 Jun 24. — View Citation
Hautala AJ, Makikallio TH, Kiviniemi A, Laukkanen RT, Nissila S, Huikuri HV, Tulppo MP. Cardiovascular autonomic function correlates with the response to aerobic training in healthy sedentary subjects. Am J Physiol Heart Circ Physiol. 2003 Oct;285(4):H1747-52. doi: 10.1152/ajpheart.00202.2003. Epub 2003 Jun 19. — View Citation
Hecksteden A, Pitsch W, Rosenberger F, Meyer T. Repeated testing for the assessment of individual response to exercise training. J Appl Physiol (1985). 2018 Jun 1;124(6):1567-1579. doi: 10.1152/japplphysiol.00896.2017. Epub 2018 Jan 11. — View Citation
Heesterbeek M, Van der Zee EA, van Heuvelen MJG. Passive exercise to improve quality of life, activities of daily living, care burden and cognitive functioning in institutionalized older adults with dementia - a randomized controlled trial study protocol. BMC Geriatr. 2018 Aug 14;18(1):182. doi: 10.1186/s12877-018-0874-4. — View Citation
Hernandez SS, Coelho FG, Gobbi S, Stella F. [Effects of physical activity on cognitive functions, balance and risk of falls in elderly patients with Alzheimer's dementia]. Rev Bras Fisioter. 2010 Jan-Feb;14(1):68-74. Portuguese. — View Citation
Hoffmann K, Sobol NA, Frederiksen KS, Beyer N, Vogel A, Vestergaard K, Braendgaard H, Gottrup H, Lolk A, Wermuth L, Jacobsen S, Laugesen LP, Gergelyffy RG, Hogh P, Bjerregaard E, Andersen BB, Siersma V, Johannsen P, Cotman CW, Waldemar G, Hasselbalch SG. Moderate-to-High Intensity Physical Exercise in Patients with Alzheimer's Disease: A Randomized Controlled Trial. J Alzheimers Dis. 2016;50(2):443-53. doi: 10.3233/JAD-150817. — View Citation
Holthoff VA, Marschner K, Scharf M, Steding J, Meyer S, Koch R, Donix M. Effects of physical activity training in patients with Alzheimer's dementia: results of a pilot RCT study. PLoS One. 2015 Apr 17;10(4):e0121478. doi: 10.1371/journal.pone.0121478. eCollection 2015. — View Citation
Huang G, Wang R, Chen P, Huang SC, Donnelly JE, Mehlferber JP. Dose-response relationship of cardiorespiratory fitness adaptation to controlled endurance training in sedentary older adults. Eur J Prev Cardiol. 2016 Mar;23(5):518-29. doi: 10.1177/2047487315582322. Epub 2015 Apr 21. — View Citation
Karavirta L, Hakkinen K, Kauhanen A, Arija-Blazquez A, Sillanpaa E, Rinkinen N, Hakkinen A. Individual responses to combined endurance and strength training in older adults. Med Sci Sports Exerc. 2011 Mar;43(3):484-90. doi: 10.1249/MSS.0b013e3181f1bf0d. — View Citation
Karlsen T, Aamot IL, Haykowsky M, Rognmo O. High Intensity Interval Training for Maximizing Health Outcomes. Prog Cardiovasc Dis. 2017 Jun-Jul;60(1):67-77. doi: 10.1016/j.pcad.2017.03.006. Epub 2017 Apr 3. — View Citation
Lam FM, Huang MZ, Liao LR, Chung RC, Kwok TC, Pang MY. Physical exercise improves strength, balance, mobility, and endurance in people with cognitive impairment and dementia: a systematic review. J Physiother. 2018 Jan;64(1):4-15. doi: 10.1016/j.jphys.2017.12.001. Epub 2017 Dec 27. — View Citation
Lautenschlager NT, Cox KL, Flicker L, Foster JK, van Bockxmeer FM, Xiao J, Greenop KR, Almeida OP. Effect of physical activity on cognitive function in older adults at risk for Alzheimer disease: a randomized trial. JAMA. 2008 Sep 3;300(9):1027-37. doi: 10.1001/jama.300.9.1027. Erratum In: JAMA. 2009 Jan 21;301(3):276. — View Citation
Lee J, Lee R, Stone AJ. Combined Aerobic and Resistance Training for Peak Oxygen Uptake, Muscle Strength, and Hypertrophy After Coronary Artery Disease: a Systematic Review and Meta-Analysis. J Cardiovasc Transl Res. 2020 Aug;13(4):601-611. doi: 10.1007/s12265-019-09922-0. Epub 2019 Oct 27. — View Citation
Lee J, Stone AJ. Combined Aerobic and Resistance Training for Cardiorespiratory Fitness, Muscle Strength, and Walking Capacity after Stroke: A Systematic Review and Meta-Analysis. J Stroke Cerebrovasc Dis. 2020 Jan;29(1):104498. doi: 10.1016/j.jstrokecerebrovasdis.2019.104498. Epub 2019 Nov 13. — View Citation
Levinger I, Shaw CS, Stepto NK, Cassar S, McAinch AJ, Cheetham C, Maiorana AJ. What Doesn't Kill You Makes You Fitter: A Systematic Review of High-Intensity Interval Exercise for Patients with Cardiovascular and Metabolic Diseases. Clin Med Insights Cardiol. 2015 Jun 25;9:53-63. doi: 10.4137/CMC.S26230. eCollection 2015. — View Citation
Lortie G, Simoneau JA, Hamel P, Boulay MR, Landry F, Bouchard C. Responses of maximal aerobic power and capacity to aerobic training. Int J Sports Med. 1984 Oct;5(5):232-6. doi: 10.1055/s-2008-1025911. — View Citation
McCleery J, Quinn TJ. Aducanumab and the certainty of evidence. Age Ageing. 2021 Nov 10;50(6):1899-1900. doi: 10.1093/ageing/afab167. No abstract available. — View Citation
Morris JK, Vidoni ED, Johnson DK, Van Sciver A, Mahnken JD, Honea RA, Wilkins HM, Brooks WM, Billinger SA, Swerdlow RH, Burns JM. Aerobic exercise for Alzheimer's disease: A randomized controlled pilot trial. PLoS One. 2017 Feb 10;12(2):e0170547. doi: 10.1371/journal.pone.0170547. eCollection 2017. — View Citation
Ohman H, Savikko N, Strandberg TE, Kautiainen H, Raivio MM, Laakkonen ML, Tilvis R, Pitkala KH. Effects of Exercise on Cognition: The Finnish Alzheimer Disease Exercise Trial: A Randomized, Controlled Trial. J Am Geriatr Soc. 2016 Apr;64(4):731-8. doi: 10.1111/jgs.14059. Epub 2016 Apr 1. — View Citation
Padala KP, Padala PR, Lensing SY, Dennis RA, Bopp MM, Roberson PK, Sullivan DH. Home-Based Exercise Program Improves Balance and Fear of Falling in Community-Dwelling Older Adults with Mild Alzheimer's Disease: A Pilot Study. J Alzheimers Dis. 2017;59(2):565-574. doi: 10.3233/JAD-170120. — View Citation
Pandey A, Swift DL, McGuire DK, Ayers CR, Neeland IJ, Blair SN, Johannsen N, Earnest CP, Berry JD, Church TS. Metabolic Effects of Exercise Training Among Fitness-Nonresponsive Patients With Type 2 Diabetes: The HART-D Study. Diabetes Care. 2015 Aug;38(8):1494-501. doi: 10.2337/dc14-2378. Epub 2015 Jun 17. — View Citation
Robinson MM, Dasari S, Konopka AR, Johnson ML, Manjunatha S, Esponda RR, Carter RE, Lanza IR, Nair KS. Enhanced Protein Translation Underlies Improved Metabolic and Physical Adaptations to Different Exercise Training Modes in Young and Old Humans. Cell Metab. 2017 Mar 7;25(3):581-592. doi: 10.1016/j.cmet.2017.02.009. — View Citation
Rodrigues SLDS, Silva JMD, Oliveira MCC, Santana CMF, Carvalho KM, Barbosa BJAP. Physical exercise as a non-pharmacological strategy for reducing behavioral and psychological symptoms in elderly with mild cognitive impairment and dementia: a systematic review of randomized clinical trials. Arq Neuropsiquiatr. 2021 Dec;79(12):1129-1137. doi: 10.1590/0004-282X-ANP-2020-0539. — View Citation
Salisbury D, Mathiason MA, Yu F. Exercise Dose and Aerobic Fitness Response in Alzheimer's Dementia: Findings from the FIT-AD Trial. Int J Sports Med. 2022 Sep;43(10):850-858. doi: 10.1055/a-1639-2307. Epub 2021 Sep 7. — View Citation
Salisbury D, Yu F. Establishing Reference Cardiorespiratory Fitness Parameters in Alzheimer's Disease. Sports Med Int Open. 2020 Jan 30;4(1):E1-E7. doi: 10.1055/a-1089-4957. eCollection 2020 Jan. — View Citation
Smith PJ, Blumenthal JA, Hoffman BM, Cooper H, Strauman TA, Welsh-Bohmer K, Browndyke JN, Sherwood A. Aerobic exercise and neurocognitive performance: a meta-analytic review of randomized controlled trials. Psychosom Med. 2010 Apr;72(3):239-52. doi: 10.1097/PSY.0b013e3181d14633. Epub 2010 Mar 11. — View Citation
Sobol NA, Hoffmann K, Frederiksen KS, Vogel A, Vestergaard K, Braendgaard H, Gottrup H, Lolk A, Wermuth L, Jakobsen S, Laugesen L, Gergelyffy R, Hogh P, Bjerregaard E, Siersma V, Andersen BB, Johannsen P, Waldemar G, Hasselbalch SG, Beyer N. Effect of aerobic exercise on physical performance in patients with Alzheimer's disease. Alzheimers Dement. 2016 Dec;12(12):1207-1215. doi: 10.1016/j.jalz.2016.05.004. Epub 2016 Jun 23. — View Citation
Song D, Yu DSF. Effects of a moderate-intensity aerobic exercise programme on the cognitive function and quality of life of community-dwelling elderly people with mild cognitive impairment: A randomised controlled trial. Int J Nurs Stud. 2019 May;93:97-105. doi: 10.1016/j.ijnurstu.2019.02.019. Epub 2019 Mar 5. — View Citation
Sugimoto T, Ono R, Murata S, Saji N, Matsui Y, Niida S, Toba K, Sakurai T. Prevalence and associated factors of sarcopenia in elderly subjects with amnestic mild cognitive impairment or Alzheimer disease. Curr Alzheimer Res. 2016;13(6):718-26. doi: 10.2174/1567205013666160211124828. — View Citation
Suttanon P, Hill KD, Said CM, Williams SB, Byrne KN, LoGiudice D, Lautenschlager NT, Dodd KJ. Feasibility, safety and preliminary evidence of the effectiveness of a home-based exercise programme for older people with Alzheimer's disease: a pilot randomized controlled trial. Clin Rehabil. 2013 May;27(5):427-38. doi: 10.1177/0269215512460877. Epub 2012 Nov 1. — View Citation
Telenius EW, Engedal K, Bergland A. Effect of a high-intensity exercise program on physical function and mental health in nursing home residents with dementia: an assessor blinded randomized controlled trial. PLoS One. 2015 May 14;10(5):e0126102. doi: 10.1371/journal.pone.0126102. eCollection 2015. — View Citation
Toots A, Littbrand H, Bostrom G, Hornsten C, Holmberg H, Lundin-Olsson L, Lindelof N, Nordstrom P, Gustafson Y, Rosendahl E. Effects of Exercise on Cognitive Function in Older People with Dementia: A Randomized Controlled Trial. J Alzheimers Dis. 2017;60(1):323-332. doi: 10.3233/JAD-170014. — View Citation
Toots A, Littbrand H, Lindelof N, Wiklund R, Holmberg H, Nordstrom P, Lundin-Olsson L, Gustafson Y, Rosendahl E. Effects of a High-Intensity Functional Exercise Program on Dependence in Activities of Daily Living and Balance in Older Adults with Dementia. J Am Geriatr Soc. 2016 Jan;64(1):55-64. doi: 10.1111/jgs.13880. — View Citation
van Uffelen JG, Chin A Paw MJ, Hopman-Rock M, van Mechelen W. The effects of exercise on cognition in older adults with and without cognitive decline: a systematic review. Clin J Sport Med. 2008 Nov;18(6):486-500. doi: 10.1097/JSM.0b013e3181845f0b. — View Citation
Yang SY, Shan CL, Qing H, Wang W, Zhu Y, Yin MM, Machado S, Yuan TF, Wu T. The Effects of Aerobic Exercise on Cognitive Function of Alzheimer's Disease Patients. CNS Neurol Disord Drug Targets. 2015;14(10):1292-7. doi: 10.2174/1871527315666151111123319. — View Citation
Yu F, Han SY, Salisbury D, Pruzin JJ, Geda Y, Caselli RJ, Li D. Feasibility and preliminary effects of exercise interventions on plasma biomarkers of Alzheimer's disease in the FIT-AD trial: a randomized pilot study in older adults with Alzheimer's dementia. Pilot Feasibility Stud. 2022 Dec 2;8(1):243. doi: 10.1186/s40814-022-01200-2. — View Citation
Yu F, Mathiason MA, Han S, Gunter JL, Jones D, Botha H, Jack C Jr. Mechanistic Effects of Aerobic Exercise in Alzheimer's Disease: Imaging Findings From the Pilot FIT-AD Trial. Front Aging Neurosci. 2021 Oct 7;13:703691. doi: 10.3389/fnagi.2021.703691. eCollection 2021. — View Citation
Yu F, Nelson NW, Savik K, Wyman JF, Dysken M, Bronas UG. Affecting cognition and quality of life via aerobic exercise in Alzheimer's disease. West J Nurs Res. 2013 Jan;35(1):24-38. doi: 10.1177/0193945911420174. Epub 2011 Sep 12. — View Citation
Yu F, Vock DM, Zhang L, Salisbury D, Nelson NW, Chow LS, Smith G, Barclay TR, Dysken M, Wyman JF. Cognitive Effects of Aerobic Exercise in Alzheimer's Disease: A Pilot Randomized Controlled Trial. J Alzheimers Dis. 2021;80(1):233-244. doi: 10.3233/JAD-201100. — View Citation
Zieschang T, Schwenk M, Becker C, Uhlmann L, Oster P, Hauer K. Falls and Physical Activity in Persons With Mild to Moderate Dementia Participating in an Intensive Motor Training: Randomized Controlled Trial. Alzheimer Dis Assoc Disord. 2017 Oct-Dec;31(4):307-314. doi: 10.1097/WAD.0000000000000201. — View Citation
* Note: There are 52 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Dementia severity | Montreal cognitive Assessment: score 0-30; higher scores reflect less impairment | measured at 0, 3, 6, 9, & 12 months | |
Other | Executive function | Trail Making Test: number of seconds required to complete the task; therefore, higher scores reveal greater impairment | measured at 0, 3, 6, 9, & 12 months | |
Other | Visuospatial ability | Benson Complex Figure: score 0-17; higher scores reflect better visuospatial abilities. | measured at 0, 3, 6, 9, & 12 months | |
Other | Language preservation | Multilingual naming test: count the number of items correctly named; higher counts reflect better language preservation | measured at 0, 3, 6, 9, & 12 months | |
Other | Fall risk | Timed up and Go: 3-meter course timed; time recorded in seconds; less time reflects lower fall risk | measured at 0, 3, 6, 9, & 12 months | |
Other | Social interaction | Engagement and Independence in Dementia Questionnaire: Scale - not true at all = 0, rarely true = 1, sometimes true = 2, often true = 3, true nearly all of the time = 4; higher ratings reflect more social interaction | measured at 0, 3, 6, 9, & 12 months | |
Other | Anxiety | Generalized Anxiety Disorder - 7: 0-21; lower scores reflect less anxiety | measured at 0, 3, 6, 9, & 12 months | |
Other | Depression | Geriatric Depression Scale: Score 1-15, lowers scores reflect less depression | measured at 0, 3, 6, 9, & 12 months | |
Primary | Peak oxygen consumption | VO2peak will be assessed from the symptom-limited peak cycle-ergometer test | measured at 0 and 6 months | |
Primary | White Matter Hyperintensity volume | WMH will be assessed from MRI. | measured at 0 and 6 months | |
Secondary | Memory | Wechsler Memory Scale - Revised; Logical Memory; score 0-50; higher scores indicate less impairment | measured at 0, 6, and 12 months | |
Secondary | Physical function | Short Physical Performance Battery: score 0-12; lower scores indicate poorer physical function | measured at 0, 3, 6, 9, & 12 months | |
Secondary | Behavioral and psychiatric symptoms of dementia (BPSD) | Neuropsychiatric Inventory Questionnaire; symptoms present, if yes, then severity and caregiver distress are reported. | measured at 1, 3, 6, 9, & 12 months | |
Secondary | Caregiver burden | 4-item Zarit Burden Interview: score 0-16; higher scores reflect greater burden | measured at 1, 3, 6, 9, & 12 months | |
Secondary | Quality of Life (QoL) | Quality of Life - AD: score 0-52; higher scores reflect greater life satisfaction | measured at 1, 3, 6, 9, & 12 months | |
Secondary | Blood amyloid-beta 42 and 40 | 20 mL blood sample collection | measured at 1, 3, 6, 9, & 12 months | |
Secondary | Blood phosphorylated tau 181 | 20 mL blood sample collection | measured at 1, 3, 6, 9, & 12 months | |
Secondary | Blood total tau, neurofilament light chain | 20 mL blood sample collection | measured at 1, 3, 6, 9, & 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04044495 -
Sleep, Rhythms and Risk of Alzheimer's Disease
|
N/A | |
Completed |
NCT04079803 -
PTI-125 for Mild-to-moderate Alzheimer's Disease Patients
|
Phase 2 | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Recruiting |
NCT04520698 -
Utilizing Palliative Leaders In Facilities to Transform Care for Alzheimer's Disease
|
N/A | |
Active, not recruiting |
NCT04606420 -
Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease
|
N/A | |
Recruiting |
NCT05820919 -
Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase
|
N/A | |
Terminated |
NCT03672474 -
REGEnLIFE RGn530 - Feasibility Pilot
|
N/A | |
Completed |
NCT03430648 -
Is Tau Protein Linked to Mobility Function?
|
||
Recruiting |
NCT04522739 -
Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease
|
Phase 4 | |
Recruiting |
NCT05288842 -
Tanycytes in Alzheimer's Disease and Frontotemporal Dementia
|
||
Recruiting |
NCT04949750 -
Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease
|
N/A | |
Recruiting |
NCT05557409 -
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation
|
Phase 3 | |
Completed |
NCT06194552 -
A Multiple Dose Study of the Safety and Pharmacokinetics of NTRX-07
|
Phase 1 | |
Completed |
NCT03239561 -
Evaluation of Tau Protein in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants
|
Early Phase 1 | |
Completed |
NCT03184467 -
Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients
|
Phase 2 | |
Active, not recruiting |
NCT03676881 -
Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
|
||
Terminated |
NCT03487380 -
Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease
|
N/A | |
Completed |
NCT05538455 -
Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases
|
N/A | |
Recruiting |
NCT05328115 -
A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease
|
Phase 1 | |
Completed |
NCT05562583 -
SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support
|
N/A |