Teleconference Minutes November 17/18, 2011

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1 Teleconference Minutes November 17/18, 2011 I. Attendance Maria Carrillo (Alzheimer s Association), Chris Rowe (AIBL), Arthur Toga, Mike Weiner (NA-ADNI), Cassandra Szoke (AIBL), Salvador Guinjoan (Arg-ADNI), Heather Snyder, Neil Buckholtz (NIA), Jun Wang (C-ADNI), Hong Zheng Wang (China), John Choi (NIA), Eric Siemers (Lily), Márcia Lorena Fagundes Chaves (Brazil), Dr. Chan (China) II. Progress Updates Reports from each of the projects will be given. - NA-ADNI, ADNI GO, ADNI2 i. Art Toga from NA-ADNI will share some information about the data storage/ access. It is mutually beneficial to get a singular place for access to data across all the countries involved in WW-ADNI. For example, Australian-ADNI or AIBL has a separate approval process that the Australian s control where they approve access and then request to gain approval is through main ADNI website. Coordinated in a seamless way for people s requests to ask for what information they want. This is an example of global cooperation and we are willing to extend to other countries interested to participate, being sensitive to your country s needs in regards to mechanisms. The goal is to make as much data available to as many people as possible as easy as possible, and we want to continue to encourage new ADNIs being sent up to share data. This will help to increase the power of the data. ii. Mike Weiner gave update on ADNI 2. ADNI 2 has finished the first year. Enrolling at reasonable rate (30 subjects/ month). If enrollment continues at this rate, ADNI 2 will complete enrollment in August of 2013 and will run project another 4 years for follow up. - E-ADNI/NEUGRID - J-ADNI i. Sent update on their efforts to Maria Carrillo via . Maria shared an updated about J-ADNI. The J-ADNI efforts have been impacted by the tsunami, however, they continue

Jun Wang (C-ADNI), Hong Zheng Wang (China), John Choi (NIA), Eric Siemers (Lily), Márcia Lorena Fagundes Chaves (Brazil), Dr. Chan (China) II.

2 to move forward and have made great progress. As of September, J-ADNI completed recruitments of 152 normal controls and 245 amcis. They will complete AD enrollment (currently at 129) by March. This data is as of September. This brings total enrollment to 526 and this is 88% of their goal. This completes their enrollment. Their follow up visits will be completed by Starting discussions of J-ADNI 2; NA-ADNI 2 will be of assistance in this process. J-ADNI is currently in the midst of their annual dementia conference. - AIBL/ A-ADNI i. AIBL studies have completed 3 year follow up, although they have experienced some drop out. In first phase, there were 1,111 people and 288 with MRI. At 3 year follow up, there are still 815 people (27% loss); imaging arm is now at 165 people (42% loss over three years). ii. There is currently funding to continue on through an additional three years (through year 6), and will look for ways to fund from the 6 year time point forward. In this next phase, they are intending to recruit 200 new people to image with florbetapir (Avid); 200 people imaged with flutemetamol (GE) and 200 people imaged with florbetaben (Bayer). iii. Cassandra Szoeke gave an update on the Healthy Aging Initiative. Recruitment is going well although they have not reached target yet. There was an update teleconference last week. iv. To summarize the project: They are testing an intervention on whether physical activity affects daily living; participant must have cognitive issues. The target enrollment is 160. To date, there are 70 enrolled. There is one arm intervention and one arm control. Each arm will receive same number of contact hours. The primary outcome is changing white matter hyperintensitivies on MRI scan. - K-ADNI - T-ADNI - Arg-ADNI i. Salvador Guinjoan gave update on the Arg-ADNI efforts. Their biggest obstacle was obtaining AV45 (florbetapir) and this has now worked out with a local provider of the agent.

Starting discussions of J-ADNI 2; NA-ADNI 2 will be of assistance in this process. J-ADNI is currently in the midst of their annual dementia conference. - AIBL/ A-ADNI i.

3 They will start recruiting volunteers after the regulatory issues have been addressed with their version of the FDA. Hoping to start recruitment in early Through private fundraising, have raised $135,000 USD which is significant (USD$1 to 4 pesos). ii. Arg-ADNI is planning to include LP and CSF measurements. They will be using Innogenetics ELISA kit. In addition, the cognitive tests are ready and they have the other technologies in place (i.e. PET Scanner, 3T scanner and cyclotron). - C-ADNI i. China ADNI has received starting funding from China government and is getting ready to distribute to participating sites. The C-ADNI clinical sites have been organized, including the set up of training workshops for the experts in the different cores to train according to NA-ADNI procedures. They have also prepared enrollment forms in Chinese language; these are compatible to NA-ADNI. ii. The MRI Core has conducted phantom test and ed to LONI for control. Although this did not work the first time, they will work with Dr. Art Toga to fix this issue. iii. The team has contacted Avid regarding access to AV45 (florbetapir). iv. C-ADNI plans to enroll 200 controls, 300 early MCI, 300 late MCI, 200 AD. v. In a parallel study that is supported by Pfizer and Wyss, they enrolled 300 cases and followed for 1 year. Patients enrolled and are continuing to do biomarkers. There are 30 centers and they will soon be able to describe the first stage of screening with data; for CSF and MRI and PET. They will use the GE compound to test and it is in route currently. - B-ADNI i. Márcia Lorena Fagundes Chaves joined for first WW-ADNI call. Recently, Brazil organized a group of centers/ colleagues to make an effort to join WW-ADNI. To date, they have gathered the expertise in the necessary areas and willing to collaborate together, both those willing to start in WW-ADNI and those willing to join later. Most of the centers are in south or southeast, but this is also where most of the research is carried out in Brazil. ii. Last month, contacted NA-ADNI and the Alzheimer s Association to learn more about the WW-ADNI to learn from others expertise.

In addition, the cognitive tests are ready and they have the other technologies in place (i.e. PET Scanner, 3T scanner and cyclotron). - C-ADNI i.

4 iii. Currently, B-ADNI is organizing the fundraising for this effort to continue the project currently. Hope next year in first quarter, will be organized enough to start collecting enrollment/ data. III. IV. DoD TBI ADNI Grant Update Mike Weiner i. ADNI 2 researchers have applied to the United States Department of Defense (DoD) for funding to study soldiers with post traumatic stress disorder (PTSD) and traumatic brain injury (TBI) to determine if either of these issues increases risk of AD and study biomarkers. Been told will be funded by about $6M; 65 people TBI; 65 people PTSD; 65 people control. Population will be elderly soldiers who are in 60s. Although have verbally been told they will receive funding, the team is waiting for official notification. Global Biomarker Standardization Consortium Kaj Blennow, Les Shaw, Philip Scheltens, Bill Potter - Group has been meeting under the leadership of Kaj Blennow, Les Shaw, Philip Scheltens, and Bill Potter. This is a result of the need for CSF assays to develop a reference material to use on global level to standardize some of the assays and assess assays. Following this, will need a reference method as well. - As a result, there are two working groups approximately 12 people in each group to discuss Reference Materials and Reference Methods respectively. These groups have started to meet. They are open to anyone maria.carrillo@alz.org if you are interested in attending. - Website is coming soon will forward to everyone. V. Research and Standardization in Alzheimer s Disease (RASAD) meeting in Melbourne Australia Program outline Chris Rowe and Colin Masters - There will be a meeting 200 to 210 attendees is goal to help the pathway to develop international standardization including imaging. Focuses will be Imaging, Biomarkers and Lifestyle. - The meeting will cover efforts around the world for standardization and hope to come up with recommendations on what the recommendations are for standardization, visual assessment verses quantification. - Regulatory authorities from US and Europe will be in attendance. - Sponsored from the Science and Industry Endowed Fund, CSIRO, Alzheimer s Association, FNIH - March in Melbourne, Australia

ADNI 2 researchers have applied to the United States Department of Defense (DoD) for funding to study soldiers with post traumatic stress disorder (PTSD) and traumatic brain injury (TBI) to determine

5 VI. New Business Future Face to Face Meeting AAICAD 2012 Vancouver - Next WW-ADNI meeting will be in Vancouver on July 13 - Maria will send a WW-ADNI announcement for the face-to-face meeting to hold date.

Total Tau, p-taup ADNI subjects at BASELINE. Leslie M Shaw John Q Trojanowski

Total Tau, p-taup ADNI subjects at BASELINE. Leslie M Shaw John Q Trojanowski Total Tau, p-taup and 181p AβA 1- in 42 CSF of ADNI subjects at BASELINE Leslie M Shaw John Q Trojanowski ADNI Biomarker Core report, April 14, 28 Biomarker studies completed or planned ASELINE CSF samples: