Feru-guard for Behavioral Symptoms in Dementia

NCT03451760 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: 17966
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is designed as a randomized, double-blind, placebo-controlled clinical trial with a 12 week intervention period. Seventy participants with a diagnosis of AD, vascular, and mixed dementia with at least 3 behavioral symptoms present from the Neuropsychiatric Inventory Questionnaires (NPI-Q) will be randomized to the Feru-guard (ferulic acid and Angelica archangelica) or placebo group. Participants will be screened first by a telephone interview or briefly in-clinic and then will be scheduled for an in-clinic screen to establish study eligibility prior to the baseline assessment visit. Clinical and biological outcome measures will occur at baseline and 12 weeks.

Conditions

Behavioral and Psychiatric Symptoms of Dementia

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Neuropsychiatric Inventory Questionnaire at 12 weeks

  The NPI-Q is a structured interview with a caregiver or qualified study partner (defined as having direct contact \> 2 days/week) that evaluates both presence and severity of 12 neuropsychiatric features which include: delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability, lability, apathy, aberrant motor behavior, night-time behavior, and appetite/ eating changes. If the response to the domain question is "No", the informant goes to the next question. If "Yes", the informant then rates both the Severity of the symptoms present within the last month on a 3-point scale ranging from 1 to 3 (mild to severe). Change in overall NPI-Q score between baseline and at 12 weeks will be the primary outcome measure.

  Administered 2 times 1 baseline, then 12 weeks later.

Secondary Outcomes (3)

• Change from Baseline Neuropsychiatric Inventory Questionnaire subscale of caregiver distress at 12 weeks

  Administered 2 times 1 baseline, then 12 weeks later.

• Change from Baseline Zarit Burden Interview Screening Version at 12 weeks

  Administered 2 times 1 baseline, then 12 weeks later.

• Change from Baseline Short Form Health Survey 12-Item at 12 weeks

  Administered 2 times 1 baseline, then 12 weeks later.

Study Arms (2)

Feru-guard

EXPERIMENTAL

Over a 12 week period participants will take two 280 mg hard gel capsules of Feru-guard 100M per day (1 capsule am, 1 capsule pm). One capsule will be taken in the morning with a meal and one capsule will be taken in the afternoon with a meal. Each capsule contains 180.32 mg ferulic acid and 20.02 mg of Angelica archangelica. Total daily dose will be 560mg of Feru-guard 100M, with 360.64 mg of ferulic acid and 40.04 mg of Angelica archangelica.

Drug: Feru-guard 100M

Placebo

PLACEBO COMPARATOR

Over a 12 week period participants will take two 280 mg hard gel capsules of a placebo per day (1 capsule am, 1 capsule pm). One capsule will be taken in the morning with a meal and one capsule will be taken in the afternoon with a meal.Total daily dosage will be 560mg of a maltodextrin, calcium stearate, and vanilla food flavor mixture.

Other: Feru-guard 100M Placebo

Interventions

Feru-guard 100M DRUG

Feru-guard is a dietary supplement commercially available in Japan in the form of a 1.5 g instant powder packet that is sold in health clinics and directly by Glovia Co. Ltd to patients on doctor's recommendation. The current study will use Feru-guard in the form of a 280 mg hard gel capsule that contains the same amount of the active ingredients (ferulic acid and Angelica archangelica) as the 1.5 g packets. In order to conduct a double-blind, placebo-controlled trial, Feru-guard is contained in opaque, hard gel capsules which allows for better matching of characteristics and improved blinding than studies using powder. Feru-guard will be supplied by Glovia, Co. Ltd., in Tokyo, Japan.

Feru-guard

Feru-guard 100M Placebo OTHER

In order to conduct a double-blind, controlled trial, the placebo will be contained in opaque, hard gel capsules which allows for better matching of characteristics and improved blinding. The placebo study drug will be matched to the Feru-guard 100M in terms of appearance, smell, and taste.

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older.
• Diagnosis of AD, vascular, and mixed dementia
• Neuropsychiatric Inventory Questionnaire (NPI-Q) at least 3 items out of 12 items are rated as "present."
• Use of cholinesterase inhibitors, antidepressants and or antipsychotics medications is allowed, if on stable dosage for at least 2 months.
• Use of memantine and/or serotonin reuptake inhibitors is also allowed, if on stable dose for at least 2 months.
• Have a committed caregiver who is able and willing to assist them with medications, provide study participant information, and attend all study visits.
• Sufficient English language skills to complete all testing.
• MMSE score of 25 or lower.

You may not qualify if:

• Participants who started using antipsychotics or anticholinergics within the previous 2 months.
• Participants on blood thinners such as warfarin (Coumadin, jantoven), rivaroxaban (xarelto), fondaparinux (arixtra), dibigatran (pradaxa), apixaban (eliquis) dalteparin (fragmin), enoxaparin (lovenox). Aspirin use is allowed.
• Participants without an identified caregiver.
• Participants with delirium caused by medicinal poisoning or drug intoxication.
• Participants who have had the following diseases before the onset of cognitive impairment:
• Alcoholism
• Manic depression or bipolar disorder
• Schizophrenia
• Participants with malignancy or an acute inflammatory disease.
• Participants with critical circulatory, respiratory, kidney, or liver disease or diabetes.
• BMI of \>30.
• Participants who have taken Feru-guard, ferulic acid, or Angelica archangelica supplementation within the last year.
• Enrollment in another clinical trial or treatment study within the previous 6 months.

Sponsors & Collaborators

• Glovia Co., Ltd.: lead
• Oregon Health and Science University: collaborator

Related Publications (60)

• Hersch EC, Falzgraf S. Management of the behavioral and psychological symptoms of dementia. Clin Interv Aging. 2007;2(4):611-21. doi: 10.2147/cia.s1698.

  PMID: 18225462 BACKGROUND

• de Oliveira AM, Radanovic M, de Mello PC, Buchain PC, Vizzotto AD, Celestino DL, Stella F, Piersol CV, Forlenza OV. Nonpharmacological Interventions to Reduce Behavioral and Psychological Symptoms of Dementia: A Systematic Review. Biomed Res Int. 2015;2015:218980. doi: 10.1155/2015/218980. Epub 2015 Nov 29.

  PMID: 26693477 BACKGROUND

• Dorey JM, Beauchet O, Thomas Anterion C, Rouch I, Krolak-Salmon P, Gaucher J, Gonthier R, Akiskal HS. Behavioral and psychological symptoms of dementia and bipolar spectrum disorders: review of the evidence of a relationship and treatment implications. CNS Spectr. 2008 Sep;13(9):796-803. doi: 10.1017/s1092852900013924.

  PMID: 18849899 BACKGROUND

• Adams BE, Tunis SL, Edell WS. Assessing antipsychotic effectiveness in dementia with the factor structure of the Psychogeriatric Dependency Rating Scale (PGDRS). J Am Med Dir Assoc. 2003 Mar-Apr;4(2):61-6. doi: 10.1097/01.JAM.0000052521.47659.7E.

  PMID: 12807576 BACKGROUND

• Herrmann N. Recommendations for the management of behavioral and psychological symptoms of dementia. Can J Neurol Sci. 2001 Feb;28 Suppl 1:S96-107. doi: 10.1017/s0317167100001268.

  PMID: 11237317 BACKGROUND

• Kar N. Behavioural and Psychological Symptoms of Dementia. In: Kar N, Jolley D, Misra N, editors. Handbook of Dementia. Hyderabad: Paras Medical Publisher; 2005. pp. 54-74.

  BACKGROUND

• Wynn ZJ, Cummings JL. Cholinesterase inhibitor therapies and neuropsychiatric manifestations of Alzheimer's disease. Dement Geriatr Cogn Disord. 2004;17(1-2):100-8. doi: 10.1159/000074281. Epub 2003 Oct 15.

  PMID: 14564129 BACKGROUND

• Mori T, Koyama N, Guillot-Sestier MV, Tan J, Town T. Ferulic acid is a nutraceutical beta-secretase modulator that improves behavioral impairment and alzheimer-like pathology in transgenic mice. PLoS One. 2013;8(2):e55774. doi: 10.1371/journal.pone.0055774. Epub 2013 Feb 8.

  PMID: 23409038 BACKGROUND

• Kimura T, Hayashida H, Murata M, Takamatsu J. Effect of ferulic acid and Angelica archangelica extract on behavioral and psychological symptoms of dementia in frontotemporal lobar degeneration and dementia with Lewy bodies. Geriatr Gerontol Int. 2011 Jul;11(3):309-14. doi: 10.1111/j.1447-0594.2010.00687.x. Epub 2011 Jan 28.

  PMID: 21272180 BACKGROUND

• Lin SY, Lewis FM. Dementia friendly, dementia capable, and dementia positive: concepts to prepare for the future. Gerontologist. 2015 Apr;55(2):237-44. doi: 10.1093/geront/gnu122. Epub 2015 Feb 15.

  PMID: 26035599 BACKGROUND

• Lyketsos CG, Lopez O, Jones B, Fitzpatrick AL, Breitner J, DeKosky S. Prevalence of neuropsychiatric symptoms in dementia and mild cognitive impairment: results from the cardiovascular health study. JAMA. 2002 Sep 25;288(12):1475-83. doi: 10.1001/jama.288.12.1475.

  PMID: 12243634 BACKGROUND

• Kales HC, Kim HM, Zivin K, Valenstein M, Seyfried LS, Chiang C, Cunningham F, Schneider LS, Blow FC. Risk of mortality among individual antipsychotics in patients with dementia. Am J Psychiatry. 2012 Jan;169(1):71-9. doi: 10.1176/appi.ajp.2011.11030347. Epub 2011 Oct 31.

  PMID: 22193526 BACKGROUND

• Haupt M, Kurz A, Janner M. A 2-year follow-up of behavioural and psychological symptoms in Alzheimer's disease. Dement Geriatr Cogn Disord. 2000 May-Jun;11(3):147-52. doi: 10.1159/000017228.

  PMID: 10765045 BACKGROUND

• Wang F, Feng TY, Yang S, Preter M, Zhou JN, Wang XP. Drug Therapy for Behavioral and Psychological Symptoms of Dementia. Curr Neuropharmacol. 2016;14(4):307-13. doi: 10.2174/1570159x14666151208114232.

  PMID: 26644152 BACKGROUND

• Prince M, Bryce R, Albanese E, Wimo A, Ribeiro W, Ferri CP. The global prevalence of dementia: a systematic review and metaanalysis. Alzheimers Dement. 2013 Jan;9(1):63-75.e2. doi: 10.1016/j.jalz.2012.11.007.

  PMID: 23305823 BACKGROUND

• Nielsen RE, Lolk A, M Rodrigo-Domingo, Valentin JB, Andersen K. Antipsychotic treatment effects on cardiovascular, cancer, infection, and intentional self-harm as cause of death in patients with Alzheimer's dementia. Eur Psychiatry. 2017 May;42:14-23. doi: 10.1016/j.eurpsy.2016.11.013. Epub 2016 Dec 12.

  PMID: 28199869 BACKGROUND

• Wang PS, Schneeweiss S, Avorn J, Fischer MA, Mogun H, Solomon DH, Brookhart MA. Risk of death in elderly users of conventional vs. atypical antipsychotic medications. N Engl J Med. 2005 Dec 1;353(22):2335-41. doi: 10.1056/NEJMoa052827.

  PMID: 16319382 BACKGROUND

• Trifiro G, Verhamme KM, Ziere G, Caputi AP, Ch Stricker BH, Sturkenboom MC. All-cause mortality associated with atypical and typical antipsychotics in demented outpatients. Pharmacoepidemiol Drug Saf. 2007 May;16(5):538-44. doi: 10.1002/pds.1334.

  PMID: 17036366 BACKGROUND

• Sosulski, F., Krygier, K., & Hogge, L. (1982). Free, esterified, and insoluble-bound phenolic acids. 3. Composition of phenolic acids in cereal and potato flours. Journal of Agricultural and Food Chemistry, 30(2), 337-340.

  BACKGROUND

• Lempereur, I., Rouau, X., & Abecassis, J. (1997). Arabinoxylan and ferulic acid variation in durum wheat (Triticum durum Desf.) grain and distribution in mill streams. J. Cereal Sci, 25, 103-110.

  BACKGROUND

• Kikuzaki H, Hisamoto M, Hirose K, Akiyama K, Taniguchi H. Antioxidant properties of ferulic acid and its related compounds. J Agric Food Chem. 2002 Mar 27;50(7):2161-8. doi: 10.1021/jf011348w.

  PMID: 11902973 BACKGROUND

• Kanski J, Aksenova M, Stoyanova A, Butterfield DA. Ferulic acid antioxidant protection against hydroxyl and peroxyl radical oxidation in synaptosomal and neuronal cell culture systems in vitro: structure-activity studies. J Nutr Biochem. 2002 May;13(5):273-281. doi: 10.1016/s0955-2863(01)00215-7.

  PMID: 12015157 BACKGROUND

• Sgarbossa A, Giacomazza D, di Carlo M. Ferulic Acid: A Hope for Alzheimer's Disease Therapy from Plants. Nutrients. 2015 Jul 15;7(7):5764-82. doi: 10.3390/nu7075246.

  PMID: 26184304 BACKGROUND

• Srinivasan M, Sudheer AR, Menon VP. Ferulic Acid: therapeutic potential through its antioxidant property. J Clin Biochem Nutr. 2007 Mar;40(2):92-100. doi: 10.3164/jcbn.40.92.

  PMID: 18188410 BACKGROUND

• Ou L, Kong LY, Zhang XM, Niwa M. Oxidation of ferulic acid by Momordica charantia peroxidase and related anti-inflammation activity changes. Biol Pharm Bull. 2003 Nov;26(11):1511-6. doi: 10.1248/bpb.26.1511.

  PMID: 14600392 BACKGROUND

• He XX, Yang XH, Ou RY, Ouyang Y, Wang SN, Chen ZW, Wen SJ, Pi RB. Synthesis and evaluation of multifunctional ferulic and caffeic acid dimers for Alzheimer's disease. Nat Prod Res. 2017 Mar;31(6):734-737. doi: 10.1080/14786419.2016.1219862. Epub 2016 Aug 17.

  PMID: 27531418 BACKGROUND

• Singh JC, Kakalij RM, Kshirsagar RP, Kumar BH, Komakula SS, Diwan PV. Cognitive effects of vanillic acid against streptozotocin-induced neurodegeneration in mice. Pharm Biol. 2015 May;53(5):630-6. doi: 10.3109/13880209.2014.935866. Epub 2014 Dec 4.

  PMID: 25472801 BACKGROUND

• Jacobson, E. A., Newmark, H., Baptista, J., & Bruce, W. R. (1983). A preliminary investigation of the metabolism of dietary phenolics in humans [Urinary metabolites of caffeic and ferulic acid]. Nutrition Reports International.

  BACKGROUND

• Sadigh-Eteghad S, Sabermarouf B, Majdi A, Talebi M, Farhoudi M, Mahmoudi J. Amyloid-beta: a crucial factor in Alzheimer's disease. Med Princ Pract. 2015;24(1):1-10. doi: 10.1159/000369101. Epub 2014 Nov 27.

  PMID: 25471398 BACKGROUND

• Tan RH, Kril JJ, Yang Y, Tom N, Hodges JR, Villemagne VL, Rowe CC, Leyton CE, Kwok JBJ, Ittner LM, Halliday GM. Assessment of amyloid beta in pathologically confirmed frontotemporal dementia syndromes. Alzheimers Dement (Amst). 2017 May 29;9:10-20. doi: 10.1016/j.dadm.2017.05.005. eCollection 2017.

  PMID: 28653036 BACKGROUND

• Simic G, Babic Leko M, Wray S, Harrington C, Delalle I, Jovanov-Milosevic N, Bazadona D, Buee L, de Silva R, Di Giovanni G, Wischik C, Hof PR. Tau Protein Hyperphosphorylation and Aggregation in Alzheimer's Disease and Other Tauopathies, and Possible Neuroprotective Strategies. Biomolecules. 2016 Jan 6;6(1):6. doi: 10.3390/biom6010006.

  PMID: 26751493 BACKGROUND

• Porat Y, Abramowitz A, Gazit E. Inhibition of amyloid fibril formation by polyphenols: structural similarity and aromatic interactions as a common inhibition mechanism. Chem Biol Drug Des. 2006 Jan;67(1):27-37. doi: 10.1111/j.1747-0285.2005.00318.x.

  PMID: 16492146 BACKGROUND

• Ono K, Hirohata M, Yamada M. Ferulic acid destabilizes preformed beta-amyloid fibrils in vitro. Biochem Biophys Res Commun. 2005 Oct 21;336(2):444-9. doi: 10.1016/j.bbrc.2005.08.148.

  PMID: 16153607 BACKGROUND

• Sul D, Kim HS, Lee D, Joo SS, Hwang KW, Park SY. Protective effect of caffeic acid against beta-amyloid-induced neurotoxicity by the inhibition of calcium influx and tau phosphorylation. Life Sci. 2009 Feb 27;84(9-10):257-62. doi: 10.1016/j.lfs.2008.12.001. Epub 2008 Dec 7.

  PMID: 19101570 BACKGROUND

• Ou, S., & Kwok, K. C. (2004). Ferulic acid: pharmaceutical functions, preparation and applications in foods. Journal of the Science of Food and Agriculture, 84(11), 1261-1269.

  BACKGROUND

• Bartus RT, Dean RL 3rd, Beer B, Lippa AS. The cholinergic hypothesis of geriatric memory dysfunction. Science. 1982 Jul 30;217(4558):408-14. doi: 10.1126/science.7046051.

  PMID: 7046051 BACKGROUND

• Bartolini M, Bertucci C, Cavrini V, Andrisano V. beta-Amyloid aggregation induced by human acetylcholinesterase: inhibition studies. Biochem Pharmacol. 2003 Feb 1;65(3):407-16. doi: 10.1016/s0006-2952(02)01514-9.

  PMID: 12527333 BACKGROUND

• Alvarez A, Opazo C, Alarcon R, Garrido J, Inestrosa NC. Acetylcholinesterase promotes the aggregation of amyloid-beta-peptide fragments by forming a complex with the growing fibrils. J Mol Biol. 1997 Sep 26;272(3):348-61. doi: 10.1006/jmbi.1997.1245.

  PMID: 9325095 BACKGROUND

• Bao F, Wicklund L, Lacor PN, Klein WL, Nordberg A, Marutle A. Different beta-amyloid oligomer assemblies in Alzheimer brains correlate with age of disease onset and impaired cholinergic activity. Neurobiol Aging. 2012 Apr;33(4):825.e1-13. doi: 10.1016/j.neurobiolaging.2011.05.003. Epub 2011 Jun 17.

  PMID: 21683475 BACKGROUND

• Wszelaki N, Paradowska K, Jamroz MK, Granica S, Kiss AK. Bioactivity-guided fractionation for the butyrylcholinesterase inhibitory activity of furanocoumarins from Angelica archangelica L. roots and fruits. J Agric Food Chem. 2011 Sep 14;59(17):9186-93. doi: 10.1021/jf201971s. Epub 2011 Aug 9.

  PMID: 21786787 BACKGROUND

• Sigurdsson S, Gudbjarnason S. Effect of oral imperatorin on memory in mice. Biochem Biophys Res Commun. 2013 Nov 15;441(2):318-20. doi: 10.1016/j.bbrc.2013.10.036. Epub 2013 Oct 16.

  PMID: 24140410 BACKGROUND

• Budzynska B, Boguszewska-Czubara A, Kruk-Slomka M, Skalicka-Wozniak K, Michalak A, Musik I, Biala G, Glowniak K. Effects of imperatorin on nicotine-induced anxiety- and memory-related responses and oxidative stress in mice. Physiol Behav. 2013 Oct 2;122:46-55. doi: 10.1016/j.physbeh.2013.08.019. Epub 2013 Aug 30.

  PMID: 23999469 BACKGROUND

• Sigurdsson S, Geirsson G, Gudmundsdottir H, Egilsdottir PB, Gudbjarnason S. A parallel, randomized, double-blind, placebo-controlled study to investigate the effect of SagaPro on nocturia in men. Scand J Urol. 2013 Feb;47(1):26-32. doi: 10.3109/00365599.2012.695390. Epub 2012 Jul 2.

  PMID: 23323790 BACKGROUND

• Kanaya, K. (2010). Effects of ferulic acid and Angelica archangelica extract (Feruguard) in patients with Alzheimer's disease. Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 6(4), S548.

  BACKGROUND

• Kimura, T. (2014). A Pilot Study of Tretment with Ferulic Acid and Angelica archangelica Extract for Cognitive Impairment. Journal of New Remedies & Clinics, 63(11), 1848-1855.

  BACKGROUND

• Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14. doi: 10.1212/wnl.44.12.2308.

  PMID: 7991117 BACKGROUND

• Kaufer DI, Cummings JL, Ketchel P, Smith V, MacMillan A, Shelley T, Lopez OL, DeKosky ST. Validation of the NPI-Q, a brief clinical form of the Neuropsychiatric Inventory. J Neuropsychiatry Clin Neurosci. 2000 Spring;12(2):233-9. doi: 10.1176/jnp.12.2.233.

  PMID: 11001602 BACKGROUND

• Morris JC. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology. 1993 Nov;43(11):2412-4. doi: 10.1212/wnl.43.11.2412-a. No abstract available.

  PMID: 8232972 BACKGROUND

• Salthouse TA. What do adult age differences in the Digit Symbol Substitution Test reflect? J Gerontol. 1992 May;47(3):P121-8. doi: 10.1093/geronj/47.3.p121.

  PMID: 1573192 BACKGROUND

• Smith T, Gildeh N, Holmes C. The Montreal Cognitive Assessment: validity and utility in a memory clinic setting. Can J Psychiatry. 2007 May;52(5):329-32. doi: 10.1177/070674370705200508.

  PMID: 17542384 BACKGROUND

• Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

  PMID: 1202204 BACKGROUND

• Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.

  PMID: 8628042 BACKGROUND

• Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998 Nov;51(11):1171-8. doi: 10.1016/s0895-4356(98)00109-7.

  PMID: 9817135 BACKGROUND

• Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.

  PMID: 7203086 BACKGROUND

• Bedard M, Molloy DW, Squire L, Dubois S, Lever JA, O'Donnell M. The Zarit Burden Interview: a new short version and screening version. Gerontologist. 2001 Oct;41(5):652-7. doi: 10.1093/geront/41.5.652.

  PMID: 11574710 BACKGROUND

• National Cancer Institute (NCI). Dietary Screener Questionnaire (DSQ) website:<http://riskfactor.cancer.gov/studies/nhanes/dietscreen/questionnaires.html>. Accessed 6 February 2012.

  BACKGROUND

• Kivipelto M, Helkala EL, Laakso MP, Hanninen T, Hallikainen M, Alhainen K, Iivonen S, Mannermaa A, Tuomilehto J, Nissinen A, Soininen H. Apolipoprotein E epsilon4 allele, elevated midlife total cholesterol level, and high midlife systolic blood pressure are independent risk factors for late-life Alzheimer disease. Ann Intern Med. 2002 Aug 6;137(3):149-55. doi: 10.7326/0003-4819-137-3-200208060-00006.

  PMID: 12160362 BACKGROUND

• Tan ZS, Seshadri S, Beiser A, Wilson PW, Kiel DP, Tocco M, D'Agostino RB, Wolf PA. Plasma total cholesterol level as a risk factor for Alzheimer disease: the Framingham Study. Arch Intern Med. 2003 May 12;163(9):1053-7. doi: 10.1001/archinte.163.9.1053.

  PMID: 12742802 BACKGROUND

• Gibson Wood W, Eckert GP, Igbavboa U, Muller WE. Amyloid beta-protein interactions with membranes and cholesterol: causes or casualties of Alzheimer's disease. Biochim Biophys Acta. 2003 Mar 10;1610(2):281-90. doi: 10.1016/s0005-2736(03)00025-7.

  PMID: 12648781 BACKGROUND

• Hixson JE, Vernier DT. Restriction isotyping of human apolipoprotein E by gene amplification and cleavage with HhaI. J Lipid Res. 1990 Mar;31(3):545-8.

  PMID: 2341813 BACKGROUND

MeSH Terms

Conditions

Behavior

Study Officials

• Lynne Shinto, N.D., M.P.H.

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Sarah Goodlin, M.D.

  Portland VA, Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason R David, B.A.

CONTACT

5034949240; dajaso@ohsu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind, placebo-controlled study. The placebos will be matched to the active supplement in both sensory and physical characteristics. The participants, study investigators, research associates, and study coordinators will have no knowledge of study assignment. Data analysis will be performed blinded to treatment status. The OHSU Research Pharmacy will be responsible for establishing a randomization scheme for newly enrolled participants. Additionally, the Research Pharmacy will ensure blinding of all study medications. The investigators will also evaluate the effectiveness of our blinding by giving study evaluators, participants, study partners, and investigators a short questionnaire asking about knowledge of group assignment. The randomization code will be broken only after data analysis or if there are numerous serious adverse events before the end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled clinical trial with a 12 week intervention period.

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: March 2, 2018
• Study Start: September 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 3, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share