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Brain Imaging Agent Approved to Help Assess Patients for Alzheimer ’s Disease, Dementia

By MedImaging International staff writers
Posted on 05 Nov 2013
A new radioactive diagnostic agent designed for use with positron emission tomography (PET) imaging of the brain in adults currently being evaluated for Alzheimer’s disease (AD) and dementia has been approved for use in the United States.

Dementia is associated with failing brain functions such as judgment, memory, language, and complex motor skills. The dementia caused by AD is tied to the accumulation in the brain of an abnormal protein called beta amyloid and damage or death of brain cells. However, beta amyloid can also be found in the brain of patients with other dementias and in elderly individuals without neurologic disorders.

The US Food and Drug Administration (FDA; Silver Springs, MD, USA) has approved Vizamyl (flutemetamol F18 injection), which works by binding to beta amyloid and producing a PET image of the brain that is used to assess the presence of beta amyloid. A negative Vizamyl scan demonstrates that there is little or no beta amyloid buildup in the brain and the cause of the dementia is probably not due to AD. A positive scan means that there is most likely a moderate or greater amount of amyloid in the brain, but it does not determine a diagnosis of AD or other dementia. Vizamyl does not replace other diagnostic tests used in the evaluation of AD and dementia.

“Many Americans are evaluated every year to determine the cause of diminishing neurologic functions, such as memory and judgment, that raise the possibility of Alzheimer’s disease,” said Shaw Chen, MD, deputy director of the Office of Drug Evaluation IV in the FDA’s Center for Drug Evaluation and Research. “Imaging drugs like Vizamyl provide physicians with important tools to help evaluate patients for AD and dementia.”

Vizamyl is the second diagnostic drug available for visualizing beta amyloid on a PET scan of the brain. In 2012, FDA approved Amyvid (Florbetapir F18 injection) to help evaluate adults for AD and other causes of cognitive decline. Vizamyl’s effectiveness was established in two clinical studies comprised of 384 participants with a range of cognitive function. All participants were injected with Vizamyl and were scanned. The images were interpreted by five independent readers masked to all clinical information. A portion of scan results were also validated by autopsy.

The study’s findings validated that Vizamyl accurately detects beta amyloid in the brain. The results also corroborate that the scans are reproducible and trained readers can accurately interpret the scans. Vizamyl’s safety was established in a total of 761 participants.

Vizamyl is manufactured for GE Healthcare (Chalfont St. Giles, UK) by Medi-Physics, Inc. (Arlington Heights, IL, USA).

Related Links:

GE Healthcare
Medi-Physics
US Food and Drug Administration


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96 (56.028366088867): SELECT show_live FROM jos_com_show_setting LIMIT 1
97 (51.021575927734): SELECT show_live FROM jos_com_show_setting LIMIT 1
98 (48.87580871582): SELECT show_live FROM jos_com_show_setting LIMIT 1
99 (42.200088500977): SELECT show_live FROM jos_com_show_setting LIMIT 1
100 (45.7763671875): SELECT show_live FROM jos_com_show_setting LIMIT 1
101 (41.961669921875): SELECT show_live FROM jos_com_show_setting LIMIT 1
102 (47.922134399414): SELECT show_live FROM jos_com_show_setting LIMIT 1
103 (42.915344238281): SELECT show_live FROM jos_com_show_setting LIMIT 1
104 (104.90417480469): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294748986 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294748986 AND published='1' LIMIT 1
105 (66.995620727539): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294748986 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294748986 AND published='1' LIMIT 1
106 (92.029571533203): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294748986 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
107 (76.055526733398): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294748986 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
108 (115.15617370605): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294748986 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294748986 AND published='1' LIMIT 1
109 (77.962875366211): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294748986 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294748986 AND published='1' LIMIT 1
110 (110.86463928223): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.id=294748986 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
111 (721.93145751953): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.id=294748986 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
112 (725.03089904785): SELECT dp.name, dp.id, dp2.name as channel, ex.name as author_name, ex.specialization, ex.images FROM jos_deeppockets as dp LEFT JOIN jos_experts as ex ON ex.id = dp.author LEFT JOIN jos_deeppockets as dp2 ON dp2.id = dp.fid WHERE dp.author != 0 AND dp.cat = 10 AND dp.published = 1 AND ( (dp.fid = 294743300) OR (dp.fid = 294743301) OR (dp.fid = 294743302) OR (dp.fid = 294743303) OR (dp.fid = 294743304) OR (dp.fid = 294743305) OR (dp.fid = 294743306) OR (dp.fid = 294743307) OR (dp.fid = 294743308) OR (dp.fid = 294743309) OR (dp.fid = 294743310) ) ORDER BY RAND() LIMIT 1
113 (552.89268493652): SELECT dp.name, dp.id, dp2.name as channel, ex.name as author_name, ex.specialization, ex.images FROM jos_deeppockets as dp LEFT JOIN jos_experts as ex ON ex.id = dp.author LEFT JOIN jos_deeppockets as dp2 ON dp2.id = dp.fid WHERE dp.author != 0 AND dp.cat = 10 AND dp.published = 1 AND ( (dp.fid = 294743300) OR (dp.fid = 294743301) OR (dp.fid = 294743302) OR (dp.fid = 294743303) OR (dp.fid = 294743304) OR (dp.fid = 294743305) OR (dp.fid = 294743306) OR (dp.fid = 294743307) OR (dp.fid = 294743308) OR (dp.fid = 294743309) OR (dp.fid = 294743310) ) ORDER BY RAND() LIMIT 1
114 (185.96649169922): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294748986 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294748986 AND published='1' LIMIT 1
115 (79.870223999023): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294748986 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294748986 AND published='1' LIMIT 1
116 (87.02278137207): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294748986 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294748986 AND published='1' LIMIT 1
117 (56.028366088867): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294748986 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294748986 AND published='1' LIMIT 1
118 (70.095062255859): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294748986 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294748986 AND published='1' LIMIT 1
119 (49.114227294922): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294748986 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294748986 AND published='1' LIMIT 1
120 (75.101852416992): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294748986 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294748986 AND published='1' LIMIT 1
121 (51.975250244141): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294748986 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294748986 AND published='1' LIMIT 1
122 (505.92422485352): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294748986 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294748986 AND type='deeppockets_item' AND published='1' LIMIT 1
123 (!!!!! 561591.14837646): ( SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.video != '' AND dp.video_source != '' AND dp.cat = 10 AND dp.published = 1 AND dp.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) UNION ( SELECT dpa.id, dpa.name, dpa.title, dpa.video, dpa.video_source, dpa.created FROM jos_deeppockets_archive AS dpa WHERE dpa.video != '' AND dpa.video_source != '' AND dpa.cat = 10 AND dpa.published = 1 AND dpa.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) ORDER BY created DESC LIMIT 3
124 (157.83309936523): ( SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.video != '' AND dp.video_source != '' AND dp.cat = 10 AND dp.published = 1 AND dp.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) UNION ( SELECT dpa.id, dpa.name, dpa.title, dpa.video, dpa.video_source, dpa.created FROM jos_deeppockets_archive AS dpa WHERE dpa.video != '' AND dpa.video_source != '' AND dpa.cat = 10 AND dpa.published = 1 AND dpa.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) ORDER BY created DESC LIMIT 3
125 (452.04162597656): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294800513 LIMIT 1
126 (61.988830566406): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294800513 LIMIT 1
127 (412.94097900391): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294800359 LIMIT 1
128 (63.896179199219): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294800359 LIMIT 1
129 (262.02201843262): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294800361 LIMIT 1
130 (66.995620727539): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294800361 LIMIT 1
131 (!!!!! 1060.962677002): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294748986 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
132 (413.17939758301): SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294748986 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
133 (201.94053649902): SELECT name FROM jos_deeppockets WHERE id=213
134 (41.961669921875): SELECT name FROM jos_deeppockets WHERE id=213
135 (501.15585327148): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))213((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
136 (411.03363037109): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))213((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
137 (102.99682617188): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294748986 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294748986 AND published='1' LIMIT 1
138 (74.863433837891): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294748986 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294748986 AND published='1' LIMIT 1
139 (243.18695068359): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294748986 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
140 (48.160552978516): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294748986 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
141 (72.956085205078): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294748986 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294748986 AND published='1' LIMIT 1
142 (60.081481933594): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294748986 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294748986 AND published='1' LIMIT 1
143 (!!!!! 1235.0082397461): SELECT jos_item.* FROM jos_item INNER JOIN jos_number ON jos_item.numberID=jos_number.id WHERE 1=1 AND (jos_item.imgMini<>'') AND jos_item.type='L' AND jos_item.numberID= ( SELECT jos_number.id FROM jos_number WHERE jos_number.journalID IN (10) and jos_number.id in (select distinct jos_number.id from jos_number join jos_item on jos_item.numberid=jos_number.id where jos_item.type='P') ORDER BY (CONVERT(SUBSTRING(issue,1,2),SIGNED) + (CONVERT(SUBSTRING(issue,3,2),SIGNED)*100)) DESC LIMIT 0,1 ) ORDER BY RAND() DESC LIMIT 6
144 (115.87142944336): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294748986 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294748986 AND published='1' LIMIT 1
145 (73.909759521484): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294748986 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294748986 AND published='1' LIMIT 1
146 (49.829483032227): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294748986 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294748986 AND type='deeppockets_item' AND published='1' LIMIT 1
147 (35.04753112793): select distinct links.* from jos_textlinks links join jos_textlinks_placement placement on links.id=placement.link_id where journal_id=(10) and (channel_id=213 or channel_id is null)
148 (37.193298339844): select distinct links.* from jos_textlinks links join jos_textlinks_placement placement on links.id=placement.link_id where journal_id=(10) and (channel_id=213 or channel_id is null)
149 (37.908554077148): SELECT livesite FROM jos_dp_categories WHERE id=10 AND published='1' LIMIT 1
150 (176.19132995605): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294748986 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294748986 AND published='1' LIMIT 1
151 (95.129013061523): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294748986 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294748986 AND published='1' LIMIT 1
152 (93.936920166016): select jos_twitters.link from jos_twitters where cat=10
153 (36.954879760742): select jos_facebook.link from jos_facebook where cat=10
154 (34.093856811523): select jos_google_plus.link from jos_google_plus where cat=10
155 (35.04753112793): select jos_linkedin.link from jos_linkedin where cat=10
156 (396.9669342041): update jos_bannersmanager_banner set impmade=impmade+1 where id in(14615,14202,14203)
157 (!!!!! 1656.0554504395): insert into jos_banners_delta values (14615,'2025-06-19 19:37:11','216.73.216.120','view'),(14202,'2025-06-19 19:37:11','216.73.216.120','view'),(14203,'2025-06-19 19:37:11','216.73.216.120','view')