The New Era of Alzheimer’sPrevention Treatment Trials          Jessica B. Langbaum, PhD  Principal Scientist, Banner Alzhe...
Debilitating   Alzheimer’s               Not a normal part of aging
Alzheimer’s vs. Dementia
Understanding Alzheimer’sThis neurological disease causes devastatingdamage, ultimately robbing an individual of mental an...
Understanding Alzheimer’sSubtle changes begin taking place in the brain years beforethe first problems with memory or thin...
Alzheimer’s by the Numbers       Alzheimer’s cost of care is projected to reach       $1.1 trillion by 2050       Someone ...
77% of U.S adults    are concerned         aboutpersonal memory loss,       while 85% are concerned over     memory loss  ...
Alzheimer’s Prevention Trials – why              now?  The urgent need  Suggested but unproven “healthy lifestyle” interve...
Preclinical Alzheimer’s DiseaseTreatments: a proposed definition“interventions started before the onset of cognitive decli...
Overview of Planned Alzheimer’s        Prevention Trials Starting in 2013Trial         Participants                     Wh...
ADCS “A4” Trial of a TBN Anti-Amyloid             Treatment        Individuals age 70-85 screened with amyloid PET     Amy...
DIAN Treatment Trials   ADAD Mutation Kindred Members -15 to +10 years from parent age of dementia                        ...
Alzheimer’s Prevention Initiative / Genentech             Treatment Trial – Colombia*• 300 participants    – 200 carriers,...
5 PS1 Mutations in Colombia
Gloria cares for her sister Maria, age 61, who developed AD symptoms in her 40s.           Photograph by Todd Heisler, Feb...
Alzheimer’s Prevention Registry    Inclusive, online community of people who are    passionate about advancing research in...
What We Hope to Accomplish    Keep enrollees informed of latest news, advocacy to                drive focus on Alzheimer’...
Our important goal is to register 100,000 people               by June 30, 2013
Joining the Registry
Visit www.endalznow.org
Complete this page…
…and this page
And you have joined!
Customize your community
Spread the Word!
Acknowledgments• Drs. Pierre Tariot, Eric Reiman, Francisco Lopera, Adam  Fleisher, Lon Schneider, Ron Thomas and many mor...
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Mci sympsium webinar nov 30 2012 langbaum

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Mci sympsium webinar nov 30 2012 langbaum

  1. 1. The New Era of Alzheimer’sPrevention Treatment Trials Jessica B. Langbaum, PhD Principal Scientist, Banner Alzheimer’s InstituteAssociate Director, Alzheimer’s Prevention Initiative Phoenix, Arizona
  2. 2. Debilitating Alzheimer’s Not a normal part of aging
  3. 3. Alzheimer’s vs. Dementia
  4. 4. Understanding Alzheimer’sThis neurological disease causes devastatingdamage, ultimately robbing an individual of mental andphysical capacityIts cause is still unknown, but a leading scientifichypothesis links Alzheimer’s to excessive build-up of theprotein amyloid in the brainSome people are at higher risk of developing Alzheimer’sbecause of their genetic background
  5. 5. Understanding Alzheimer’sSubtle changes begin taking place in the brain years beforethe first problems with memory or thinking appearAdvanced imaging, biomarker techniques and sophisticatedcognitive measures can detect these changes in brainstructure and functionPromising treatments may need to be started at the pre-symptomatic stage of the disease to have their mostprofound effect
  6. 6. Alzheimer’s by the Numbers Alzheimer’s cost of care is projected to reach $1.1 trillion by 2050 Someone is diagnosed with Alzheimer’s every 6.9 seconds in this country 5.4 million Americans are currently affected by Alzheimer’s Alzheimer’s is the 6th leading cause of death in the United States Alzheimer’s is the only top 10 cause of death that cannot be prevented, treated or cured
  7. 7. 77% of U.S adults are concerned aboutpersonal memory loss, while 85% are concerned over memory loss in loved ones
  8. 8. Alzheimer’s Prevention Trials – why now? The urgent need Suggested but unproven “healthy lifestyle” interventions Investigational Alzheimer’s disease modifying treatments “Too little too late” Biomarkers & sensitive cognitive measures
  9. 9. Preclinical Alzheimer’s DiseaseTreatments: a proposed definition“interventions started before the onset of cognitive decline and intended to postpone the onset, reduce the risk of, or completely prevent Alzheimer’s symptoms” Reiman et al, Biomarkers Med 2010
  10. 10. Overview of Planned Alzheimer’s Prevention Trials Starting in 2013Trial Participants Where? Treatment Trial SpecificsADCS “A4” •1,000 •US TBN •3 year clinical trial •Age 70 - 85 1000 amyloid+ randomized 1:1 •Interim analysis at • Amyloid + treatment to placebo 18months for •500 amyloid- in natural biomarkers history studyAPI • 300 in Colombia •US crenezumab (Genentech) •5 year clinical trial • ~ 30 in US •Colombia 200 carriers randomized 1:1 •interim analysis at • Age 30-60 treatment to placebo; 100 year 2 • ADAD kindred noncarriers to placeboDIAN • 240 •US • gantenerumab (Roche) •2 year biomarker trial •Age -15 to +10 years •Europe • solanezumab (Eli Lily) •will decide which compared to parent age •Australia Potential: treatment to continue of onset •Others may • BACE inhibitor (Eli Lilly) for 3 year trial • ADAD kindred be added •160 carriers randomized to 3 drug arms or placebo; ~80 noncarriers to placeboZinfandel / •4, 000 •US • pioglitazone (Takeda)Takeda •Age 62-83 • TOMM40+
  11. 11. ADCS “A4” Trial of a TBN Anti-Amyloid Treatment Individuals age 70-85 screened with amyloid PET Amyloid+ Amyloid+ Amyloid- (n =500) (n =500) (n= 500) TREATMENT PLACEBO Natural History ARM ARM Study RCT PORTION OF STUDY
  12. 12. DIAN Treatment Trials ADAD Mutation Kindred Members -15 to +10 years from parent age of dementia onsetADAD ADAD ADAD ADAD ADADcarrier carrier carrier carrier non-carrier(n = 40) (n = 40) (n = 40) (n = 40) (n = 80)gantenerumab solanezumab BACE Pooled placebo placebo (added later) RCT PORTION OF STUDY COHORT PORTION OF STUDY
  13. 13. Alzheimer’s Prevention Initiative / Genentech Treatment Trial – Colombia*• 300 participants – 200 carriers, 100 noncarriers – Standard of care is not to disclose genetic status• up to 18 months for enrollment• 104-260 week trial in 200 carriers to study efficacy of treatment by comparing change in in cognition and biomarkers• Natural history (“cohort study”) of 100 placebo-treated carrier & non-carriers * A separate US protocol will enroll ~30 carriers and non-carriers in a similar fashion
  14. 14. 5 PS1 Mutations in Colombia
  15. 15. Gloria cares for her sister Maria, age 61, who developed AD symptoms in her 40s. Photograph by Todd Heisler, February 2009, courtesy of the NY Times, with permission
  16. 16. Alzheimer’s Prevention Registry Inclusive, online community of people who are passionate about advancing research in Alzheimer’s Designed to help generate critical public awareness around the disease A shared resource benefiting the general research community and organizations nationwide People in the Registry may have the opportunity to participate in research studies within their community • Participants are sent emails informing them of potential study opportunities, but are never any obligation to join a study • All information is kept confidential and is not shared without your explicit permission
  17. 17. What We Hope to Accomplish Keep enrollees informed of latest news, advocacy to drive focus on Alzheimer’s Provide an unprecedented resource of potential study participants for prevention research , decreasing enrollment time Offer valuable resources of simple, easy to understand news in partnership with AlzForum
  18. 18. Our important goal is to register 100,000 people by June 30, 2013
  19. 19. Joining the Registry
  20. 20. Visit www.endalznow.org
  21. 21. Complete this page…
  22. 22. …and this page
  23. 23. And you have joined!
  24. 24. Customize your community
  25. 25. Spread the Word!
  26. 26. Acknowledgments• Drs. Pierre Tariot, Eric Reiman, Francisco Lopera, Adam Fleisher, Lon Schneider, Ron Thomas and many more from the Alzheimer’s Prevention Initiative• Drs. Reisa Sperling and Paul Aisen from ADCS “A4”• Drs. Randy Bateman, John Morris and Anne Fagan from DIAN• Colleagues from the Collaboration for Alzheimer’s Prevention• Colleagues from Genentech• National Institute on Aging, Geoffrey Beene Gives Back Alzheimer’s Initiative and Banner Alzheimer’s Foundation

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