BrainBlog

From Fierce Biotech : Key AZ/Targacept depression drug flunks first Phase III test By John Carroll November 8, 2011 — 6:49am ET [snippet] "The high-profile depression drug TC-5214 has failed the first in a string of Phase III studies, dealing AstraZeneca's struggling R&D operation another stinging setback and walloping Targacept with a meltdown in its share value this morning." [snippet] Read the full article

Parliamentary Office of Science and Technology POSTNote October 2011 POSTNote: Clinical Trials (pdf).

A randomized, double-blind, placebo-controlled trial of simvastatin to treat Alzheimer disease. Neurology . 2011 Aug 9;77(6):556-63 Sano M, Bell KL, Galasko D, Galvin JE, Thomas RG, van Dyck CH, Aisen PS Abstract BACKGROUND: Lowering cholesterol is associated with reduced CNS amyloid deposition and increased dietary cholesterol increases amyloid accumulation in animal studies. Epidemiologic data suggest that use of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) may decrease the risk of Alzheimer disease (AD) and a single-site trial suggested possible benefit in cognition with statin treatment in AD, supporting the hypothesis that statin therapy is useful in the treatment of AD. OBJECTIVE: To determine if the lipid-lowering agent simvastatin slows the progression of symptoms in AD. METHODS: This randomized, double-blind, placebo-controlled trial of simvastatin was conducted in individuals with mild to moderate AD and normal lipid levels. Participants were...

A phase 2 randomized trial of ELND005, scyllo-inositol, in mild to moderate Alzheimer disease. Neurology . 2011 Sep 14; Authors: Salloway S, Sperling R, Keren R, Porsteinsson AP, van Dyck CH, Tariot PN, Gilman S, Arnold D, Abushakra S, Hernandez C, Crans G, Liang E, Quinn G, Bairu M, Pastrak A, Cedarbaum JM. Abstract OBJECTIVE:This randomized, double-blind, placebo-controlled, dose-ranging phase 2 study explored safety, efficacy, and biomarker effects of ELND005 (an oral amyloid anti-aggregation agent) in mild to moderate Alzheimer disease (AD). METHODS:A total of 353 patients were randomized to ELND005 (250, 1,000, or 2,000 mg) or placebo twice daily for 78 weeks. Coprimary endpoints were the Neuropsychological Test Battery (NTB) and Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale. The primary analysis compared 250 mg (n = 84) to placebo (n = 82) after an imbalance of infections and deaths led to early discontinuation of the 2 higher dose groups. ...

J&J Will Seek FDA Approval by 2013 for Alzheimer’s Drug Bloomberg News By Alex Nussbaum May 26, 2011 10:38 AM CT Read the news article

FierceBiotechResearch has an article which presents a very brief overview of the current Alzheimer's disease drug pipeline: It is available at the link below: Making sense of the Alzheimer's drug pipeline FierceBiotechResearch March 15, 2011 — 7:53am ET By Howard Lovy Read the full article If this area is new to you, the article will give you the names of some candidates that you can learn about as part of your introduction. There are many other overview articles and public resources available to you concerning clinical-trials research. You might wish, for example, to cross reference the names cited here with the ClinicalTrials.gov database. If you are a Brain Awareness Week visitor, you can visit the Alzheimer's Association or other national organizations in your country to learn more about Alzheimer's disease and dementia.

From FierceBiotech , an interesting report: Full article: Top 10 Phase III Failures of 2010

Chen Y, Li YS, Wang ZY, Xu Q, Shi GW, & Lin Y. [The efficacy of donepezil for post-stroke aphasia: a pilot case control study.] Zhonghua Nei Ke Za Zhi. 2010 Feb, 49(2), 115-118. OBJECTIVE: To evaluate the efficacy of donepezil for post-stroke aphasia. METHODS: Sixty patients with acute post-stroke aphasia were divided into treatment group and a control group. All patients had been treated for secondary prevention according to the guideline. The treatment group received donepezil hydrochloride (5 mg/d) for 12 weeks. The efficacy of treatment was measured by comparing the changes of scores of Western Aphasia Battery (WAB) between baseline and 12 weeks later. RESULTS: Compared with the baseline, the changes of scores of all items of WAB and Aphasia Quotient (AQ) in both group after 12 weeks follow-up were great, however, the change of AQ was significantly greater in donepezil group (34.14 +/- 17.70)than that in control group (20.69 +/- 17.26)(P = 0.004). The patients in donepezil gr...

Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis (SURPASS): ClinicalTrials.gov Description === Corporate press release ===

Santoro A, Siviero P, Minicuci N, Bellavista E, Mishto M, Olivieri F, Marchegiani F, Chiamenti AM, Benussi L, Ghidoni R, Nacmias B, Bagnoli S, Ginestroni A, Scarpino O, Feraco E, Gianni W, Cruciani G, Paganelli R, Di Iorio A, Scognamiglio M, Grimaldi LM, Gabelli C, Sorbi S, Binetti G, Crepaldi G, & Franceschi C. Effects of donepezil, galantamine and rivastigmine in 938 italian patients with Alzheimer's disease: A prospective, observational study. CNS Drugs. 2010 Feb 1; 24(2): 163-176. doi: 10.2165/11310960-000000000-00000. Department of Experimental Pathology, University of Bologna, Via S. Giacomo 12, Bologna, Italy. Acetylcholinesterase inhibitors (AChEIs) have been used to improve cognitive status and disability in patients with mild to moderate Alzheimer's disease (AD). However, while the efficacy of AChEIs (i.e. how they act in randomized controlled trials) in this setting is widely accepted, their effectiveness (i.e. how they behave in the real world) remains controv...

A press release from earlier today by Pfizer: Pfizer And Medivation Announce Results From Two Phase 3 Studies In Dimebon (latrepirdine) Alzheimer’s Disease Clinical Development Program [snip] "About the CONNECTION Study "CONNECTION is a Phase 3, multi-national, double-blind, placebo-controlled safety and efficacy trial involving 598 patients with mild-to-moderate AD at 63 sites in North America, Europe, and South America. Patients had a mean age of 74.4 years and a mean score of 17.7 on the Mini-Mental State Examination (MMSE) upon entry into the study. More than 40 percent of the patients enrolled were in the United States. In the study, patients were randomized to one of three treatment groups, receiving dimebon 20 mg three times a day (TID), dimebon 5 mg TID, or placebo TID for six months. The 5 mg arm was included in the study to help define the effective dose range for dimebon treatment. "No statistically significant improvements for the 20 mg TID group relative to ...

From Fierce Biotech : UCSF enters drug discovery agreement with Genentech Posted February 19, 2010 "The University of California, San Francisco has signed a partnership agreement with Genentech, Inc., a wholly owned member of the Roche Group, to discover and develop drug candidates for neurodegenerative diseases. "Through the agreement, Genentech will provide funding and its research acumen in neuroscience and will collaborate with UCSF to identify small molecules." Read the full article

From The Guardian : Sex hormone progesterone may save lives after brain injury A major clinical trial will test whether the female sex hormone can minimise damage and improve recovery after brain injury Ian Sample, San Diego guardian.co.uk Friday 19 February 2010 21.30 GMT An article about the proTECT III clinical trial. Read the article === Here is the ClinicalTrials.gov entry for this study: proTECT III ===

Novartis, Merck KGaA Pills Bring ‘New Horizon’ for MS (Update1) By Naomi Kresge Bloomberg 20 January 2010 "Jan. 20 (Bloomberg) -- The first oral medicines for multiple sclerosis from Novartis AG and Merck KGaA may offer patients who are willing to run the risk of infections and other side effects an easier route toward treating the debilitating neurological disease, according to three studies." (The drugs are immunosuppressive.) Read full article

FierceBiotech reported today about a failed Phase III trial of Acadia's Pimavanserin in a study of Parkinson's Disease Psychosis (sometimes abbreviated as "PDP"): ACADIA Pharmaceuticals Announces Results from Phase III Trial of Pimavanserin in Parkinson's Disease Psychosis Pimavanserin Misses Primary Endpoint of Antipsychotic Efficacy; Meets Key Secondary Endpoint of Motoric Tolerability [snip] SAN DIEGO -- Sep. 1, 2009-- ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) today announced top-line results from the first pivotal Phase III trial with pimavanserin in patients with Parkinson's disease psychosis, or PDP. The study did not meet its primary endpoint of antipsychotic efficacy as measured using the Scale for the Assessment of Positive Symptoms, or SAPS. Pimavanserin met the key secondary endpoint of motoric tolerability as measured using the Unified Parkinson's Disease Rating Scale , or UPDRS. Pimavanserin was safe and well tolerated, with the frequency of...

C-SPAN-3 is currently airing an earlier session by the subcommittee on aging on the topic of Alzheimer's Disease. All C-SPAN channels can be streamed online. Information about the program can be found here .

Following up on a posting earlier this week: From a General Electrics press release 11 August 2009 FDA ADVISORY COMMITTEE RECOMMENDS DaTSCAN™ (Ioflupane I 123 Injection) PRINCETON, NJ--GE Healthcare announced today that the Peripheral and Central Nervous System Drugs advisory committee of the U.S. Food and Drug Administration (FDA) has voted to recommend DaTSCAN (Ioflupane I 123 Injection) to the FDA. The panel determined DaTSCAN has a favorable risk to benefit profile, voting 11 to two with one abstention. The proposed indication for DaTSCAN is for the visualization of the dopamine transporter (DaT) distribution within the striata by single photon emission computed tomography (SPECT) imaging in patients presenting with symptoms or signs suggestive of dopaminergic neurodegeneration. In May 2009, the FDA accepted the New Drug Application and granted DaTSCAN priority review, a designation identified for areas of unmet medical need. If approved, DaTSCAN will be the first radiopharmaceut...

Lu PH, Edland SD, Teng E, Tingus K, Petersen RC, Cummings JL & Alzheimer's Disease Cooperative Study Group. (2009) Donepezil delays progression to AD in MCI subjects with depressive symptoms. Neurology, 72(24): , 2115-2121. Departments of Neurology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA. OBJECTIVE: To determine whether the presence of depression predicts higher rate of progression to Alzheimer disease (AD) in patients with amnestic mild cognitive impairment (aMCI) and whether donepezil treatment beneficially affect this relationship. METHODS: The study sample was composed of 756 participants with aMCI from the 3-year, double-blind, placebo-controlled Alzheimer's Disease Cooperative Study drug trial of donepezil and vitamin E. Beck Depression Inventory (BDI) was used to assess depressive symptoms at baseline and participants were followed either to the end of study or to the primary endpoint of progression to probable or possible AD. RESULTS: Cox pr...

A Bloomberg News report about the state of clinical trials of those Alzheimer's disease candidates in the processes/stages in amyloid levels and amyloid deposition: read article here

Alphavax , of Research Triangle Park, reported completing preclinical work and is developing product for clinical trials of its H1N1 (Swine Flu) vaccine, per company press release ( click here ). GlaxoSmithKline (GSK) tasks order for 195 million doses of vaccine The Times (UK) click here