Skip to main content
Log in

Efficacy of a medical food on cognition in Alzheimer’s Disease: Results from secondary analyses of a randomized, controlled trial

  • Effects of a Medical Food on Cognition in AD
  • Published:
The journal of nutrition, health & aging

Abstract

Objective

To investigate the extent that baseline cognitive impairment and intake adherence affected the 13-item Alzheimer’s Disease Assessment Scale — cognitive subscale (ADAS-cog) intervention response of a medical food in Alzheimer’s Disease (AD) patients.

Desigrt/setting/participants /intervention/measurements

This analysis was performed on data from a proof-of-concept study, consisting of a 12-week, double-blind, randomized, controlled, multicenter trial, followed by a similarly designed 12-week extension study. Patients with mild AD (Mini-Mental State Examination [MMSE] score of 20–26) were randomized to receive active or control product as a 125 ml daily drink. One of the co-primary outcome measures was the 13-item ADAS-cog. In this analysis, the study population was divided into two subgroups: patients with ‘low’ baseline ADAS-cog scores (<25.0) and patients with ‘high baseline ADAS-cog scores (≥25.0). Repeated Measures Models (RMM) were used to determine the relationship between ADAS-cog score and intervention.

Results

A significant treatment effect (F[1,319]=4.0, p=0.046) was shown in patients with ‘high baseline ADAS-cog, but not in patients with ‘low’ baseline ADAS-cog (F[1,250]= 1.25, p=0.265). Overall, intake adherence was significantly correlated with ADAS-cog improvement in the active product group (correlation coefficient=−0.260; p=0.019), but not the control group.

Conclusion

These data indicate that baseline ADAS-cog significantly influenced the effect of Souvenaid intervention on ADAS-cog outcome. A higher intake of active study product was also associated with greater cognitive benefit. These findings highlight the potential benefits of Souvenaid in AD patients and warrant confirmation in larger, controlled studies.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Similar content being viewed by others

References

  1. Rosenstein LD (1998) Differential diagnosis of the major progressive dementias and depression in middle and late adulthood a summary of the literature of the early 1990s. Neuropsychol Rev 8 (3): 109–167.

    Article  Google Scholar 

  2. Selkoe DJ(2002) Alzheimer’s disease is asynaptic failure. Science 298:789–791.

    Google Scholar 

  3. Terry RD (2006) Alzheimer’s disease and the aging brain. J Geriatr Psychiatry Neurol 19 (3): 125–128.

    Article  Google Scholar 

  4. Wurtman RJ, Ulus IH, Cansev M, Watkins CJ, Wang L, and Marzloff G (2006) Synaptic proteins and phospholipids are increased in gerbil brain by administering uridine plus docosahexaenoic acid orally. Brain Res 1088(1):83–92.

    Article  PubMed  CAS  Google Scholar 

  5. Cansev M and Wurtman RJ (2007) Chronic administration of docosahexaenoic acid or eicosapentaenoic acid, but not arachidonic acid, alone or in combination with uridine, increases brain phosphatide and synaptic protein levels in gerbils. Neuroscience 148(2): 421–431.

    Article  PubMed  CAS  Google Scholar 

  6. Cansev M, Wurtman RJ, Sakamoto T, and Ulus IH (2008) Oral administration of circulating precursors for membrane phosphatides can promote the synthesis of new brain synapses. Alzheimeis Dement 4(1 Suppl 1):S153–S168.

    Article  CAS  Google Scholar 

  7. Sakamoto T, Cansev M, and Wurtman RJ (2007) Oral supplementation with docosahexaenoic acid and uridine-5′-monophosphate increases dendritic spine density in adult gerbil hippocampus. Brain Res 1182:50–59.

    Article  PubMed  CAS  Google Scholar 

  8. Arellano JI, Espinosa A, Fairen A, Yuste R, and DeFelipe J (2007) Non-synaptic dendritic spines in neocortex. Neuroscience 145(2):464–469.

    Article  PubMed  CAS  Google Scholar 

  9. Toni N, Teng EM, Bushong EA, Aimone JB, Zhao C, Consiglio A, van Praag H, Marione ME, Ellisman MH, and Gage EH (2007) Synapse formation on neurons bom in the adult hippocampus. NatNeurosci 10 (6):727–34.

    Google Scholar 

  10. Hering H and Sheng M (2001) Dendritic spines: structure, dynamics and regulation. Nat Rev Neurosci 2 (12):880–888.

    Article  Google Scholar 

  11. US Department of Health and Human Services FaDA, Center for Food Safety and Applied Nutrition, Frequently Asked Questions About Medical Foods. 2007.

  12. Scheltens P, Kamphuis PJ, Verhey FR, Olde Rikkert MG, Wurtman RJ, Wilkinson D, Twisk JW, and Kurz A (2010) Efficacy of a medical food in mild Alzheimer’s disease: A randomized, controlled trial. Alzheimers Dement 6 (1):1–10el.

    Article  Google Scholar 

  13. Mohs RC, Knopman D, Petersen RC, Ferris SH, Ernesto C, Grundman M, Sano M, Bieliauskas L, Geldmacher D, Clark C, and Thai LJ (1997) Development of cognitive instruments for use in clinical trials of antidementia drugs: additions to the Alzheimer’s Disease Assessment Scale that broaden its scope. The Alzheimer’s Disease Cooperative Study. Alzheimer Dis Assoc Disord 11Suppl 2:S13–S21.

    Article  PubMed  Google Scholar 

  14. Wechsler D (1987) Wechsler Memory Scale — Revised Manual. San Diego: Psychological corp.

    Google Scholar 

  15. Littell RC, Milliken GA, Stroup WW, and Wolfinger RD (1996) SAS? System for Mixed Models. Cary, NC: SAS Institute, Inc. 633.

    Google Scholar 

  16. Fitzmaurice G, Laird N, and Ware J (2004) Applied longitudinal analysis. Hoboken, New Jersey: John Wiley & Sons.

    Google Scholar 

  17. Black R, Greenberg B, Ryan JM, Posner H, Seeburger J, Amatniek J, Resnick M, Mohs R, Miller DS, Saumier D, Carrillo MC, and Stern Y (2009) Scales as outcome measures for Alzheimer’s disease. Alzheimers Dement 5(4):324–39.

    Article  PubMed  Google Scholar 

  18. Vellas B, Andrieu S, Sampaio C, and Wilcock G (2007) Disease-modifying trials in Alzheimer’s disease: a European task force consensus. Lancet Neurol 6(1):56–62.

    Article  PubMed  Google Scholar 

  19. Benge JF, Balsis S, Geraci L, Massman PJ, and Doody RS (2009) How well do the ADAS-cog and its subscales measure cognitive dysfunction in Alzheimer’s disease? Dement GeriatrCogn Disord 28(1):63–69.

    Article  CAS  Google Scholar 

  20. Ferris SH, Lucca U, Mohs R, Dubois B, Wesnes K, Erzigkeit H, Geldmacher D, and Bodick N (1997) Objective psychometric tests in clinical trials of dementia drugs. Position paper from the International Working Group on Harmonization of Dementia Drug Guidelines. Alzheimer Dis Assoc Disord 11 Suppl3:34–38.

    Google Scholar 

  21. Jones RW, Schwam E, Wilkinson D, Waldemar G, Feldman HH, Zhang R, Albert K, and Schindler R (2009) Rates of cognitive change in Alzheimer disease: Observations across a decade of placebo-controlled clinical trials with donepezil. Alzheimer Dis Assoc Disord 23(4):357–364.

    Article  PubMed  CAS  Google Scholar 

  22. Schneider LS and Sano M (2009) Current Alzheimer’s disease clinical trials: methods and placebo outcomes. Alzheimers Dement 5(5):388–397.

    Article  PubMed  Google Scholar 

  23. Stern RG, Mohs RC, Davidson M, Schmeidler J, Silverman J, Kramer-Ginsberg E, Searcey T, Bierer L, and Davis KL (1994) A longitudinal study of Alzheimer’s disease: measurement, rate, and predictors of cognitive deterioration. Am J Psychiatry 151(3):390–396.

    PubMed  CAS  Google Scholar 

  24. Ito K, Ahadieh S, Corrigan B, French J, Fullerton T, and Tensfeldt T Disease progression meta-analysis model in Alzheimer’s disease. Alzheimers Dement 6(1):39–53.

  25. Seltzer B, Zolnouni P, Nunez M, Goldman R, Kumar D, Ieni J, and Richardson S (2004) Efficacy of donepezil in early-stage Alzheimer disease: a randomized placebo-controlled trial. Arch Neurol 61(12): 1852–1856.

    Article  PubMed  Google Scholar 

  26. Green RC, Schneider LS, Amato DA, Beelen AP, Wilcock G, Swabb EA, and Zavitz KH (2009) Effect of tarenflurbil on cognitive decline and activities of daily living in patients with mild Alzheimer disease: a randomized controlled trial. Jama 302(23):2557–2564.

    Article  PubMed  CAS  Google Scholar 

  27. Van Gool WA, Weinstein HC, Scheltens P, and Walstra GJ (2001) Effect of hydroxychloroquine on progression of dementia in early Alzheimer’s disease: an 18-month randomised, double-blind, placebo-controlled study. Lancet 358(9280):455–460.

    Article  PubMed  Google Scholar 

  28. Hampel H, Ewers M, Burger K, Annas P, Mortberg A, Bogstedt A, Frolich L, Schroder J, Schonknecht P, Riepe MW, Kraft I, Gasser T, Leyhe T, Moller HJ, Kurz A, and Basun H (2009) Lithium trial in Alzheimer’s disease: a randomized, single-blind, placebo-controlled, multicenter 10-week study. J Clin Psychiatry 70(6):922–931.

    Article  PubMed  CAS  Google Scholar 

  29. Vellas B, Andrieu S, Sampaio C, Coley N, and Wilcock G (2008) Endpoints fortrials in Alzheimer’s disease: a Europe an task force consensus. Lancet Neurol 7(5):436–450.

    Article  PubMed  CAS  Google Scholar 

  30. Sampaio C (2007) Clinical relevance on Alzheimer’s disease endpoints. J Nutr Health Aging 11(4):316–317.

    PubMed  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Philip Scheltens.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Kamphuis, P.J.G.H., Verhey, F.R.J., Olde Rikkert, M.G.M. et al. Efficacy of a medical food on cognition in Alzheimer’s Disease: Results from secondary analyses of a randomized, controlled trial. J Nutr Health Aging 15, 720–724 (2011). https://doi.org/10.1007/s12603-011-0105-6

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s12603-011-0105-6

Key words

Navigation