Clinical trial: A Safety and Efficacy Study Evaluating Dimebon (Latrepirdine) in Patients With Moderate to Severe Alzheimer's Disease (CONTACT) http://clinicaltrials.gov/ct2/show/NCT00954590
Generic name: dimebolin Product Brand Name: Latrepirdine Product Manufacturer: Pfizer (known as Dimebon in Russia)
Latrepirdine description
Newest Alzheimer's drug: DIMEBON (LATREPIRDINE)
Dimebon (latrepirdine) Shown to be Well-Tolerated in a Four-Week Combination. In another study presented earlier in the week, Medivation and Pfizer announced that the investigational drug dimebon (latrepirdine) was well-tolerated when used in combination with donepezil HCl tablets. In this Phase 1, four-week, placebo-controlled safety study, 24 patients with Alzheimer's disease on a stable dose of donepezil for at least 60 days were randomized to receive dimebon (latrepirdine) or placebo for two to four weeks.(2)
The first group of patients enrolled (dimebon, n=9, placebo, n=5) underwent gradual dose-titration in one-week intervals ranging from 2.5 mg three times daily (TID) up to 20 mg TID, over one month. The second group of patients (dimebon, n=6, placebo, n=4) titrated from 10 mg TID for one week to 20 mg TID for one week. No serious adverse events were reported in the study.(2) The most commonly reported adverse events compared to placebo were fatigue (dimebon, n=3/15, placebo, n=0), abdominal distension (dimebon, n=2/15, placebo, n=0), fall (dimebon, n=2/15, placebo, n=0), hyperkalemia (dimebon, n=2/15, placebo, n=1/9) and nightmare (dimebon, n=2/15, placebo, n=0). These events were mild to moderate in severity and resolved with continued treatment.(2)
In addition to PF-04360365 and dimebon (latrepirdine), Pfizer is investigating several other compounds targeting different pathways for the treatment of Alzheimer's disease.
About Dimebon (latrepirdine)
Dimebon (latrepirdine) is an investigational compound for the treatment of Alzheimer's disease. Three Phase 3 trials are underway and two additional Phase 3 trials are scheduled to start later this year. CONCERT is a 12-month clinical trial examining the safety and efficacy of dimebon (latrepirdine) when added to donepezil in patients with mild to moderate Alzheimer's disease, which recently began enrollment. CONCERT is designed to complement previous and ongoing studies evaluating the potential for dimebon (latrepirdine) to be used as monotherapy, as well as in combination with donepezil.
Based on preclinical studies completed thus far, dimebon (latrepirdine) is thought to potentially stabilize or improve mitochondrial function in a way that prevents neurons from damage and dysfunction. The mechanism of action of dimebon (latrepirdine) is thought to be distinct from currently available Alzheimer's medications.
* Latrepirdine is the proposed generic (nonproprietary) name for dimebon.
26 November, 2009
Study Set To Provide Breakthrough In Treatment Of Alzheimer’s
A ground-breaking clinical trial which could help halt the onset of advanced Alzheimer's and dramatically improve the quality of life for patients and carers has been launched in the UK.
Glasgow Memory Clinic is now enrolling patients in the CONCERT trial, a one-year international study set up to test the effectiveness of a unique investigational drug, dimebon (also known by its proposed generic name of latrepirdine), in patients currently taking Aricept (donepezil HCI tablets), the leading medication for Alzheimer's disease worldwide.
More than 1,000 patients from across western Europe, the United States, Australia and New Zealand will take part in the CONCERT trial and it is hoped that the combined medication will help stabilise the condition of those with Alzheimer's by safely improving cognition (thinking and awareness), memory, daily functioning, behaviour and the ability to care for oneself.
Glasgow Memory Clinic has already enrolled a number of patients onto the trial and still has spaces available for those who meet the eligibility criteria.
Dr Fraser Inglis, Consultant Physician and founder of the Glasgow Memory Clinic, is optimistic about the advances the trial may make in the treatment of Alzheimer's disease.
"Alzheimer's is a complex disease and while current medications may improve the symptoms for some patients for a time, often the disease continues to progress. Therefore, combination therapy may be the method to maximise clinical benefit," said Dr Inglis.
"CONCERT is an important study because dimebon is thought to work differently to current medications and this study will evaluate whether adding it to one of the most commonly used Alzheimer's medications will provide a more effective symptomatic treatment to patients, stabilising their condition and ultimately improving their quality of life.
"A cure for Alzheimer's is still many years away, however treatments that provide lasting effects, more symptomatic benefits or slow disease progression would offer meaningful benefits for patients and their carers. For this reason, there is an urgent need for patients to participate in clinical trials such as CONCERT and help advance the understanding of how Alzheimer's disease can be better treated."
The Alzheimer's Society estimates that as many as 417,000 people in the UK are living with Alzheimer's, a devastating disease that hinders the patient's ability to remember, learn, perform daily activities and relate to others. As the baby boomer population ages, the incidence of Alzheimer's is expected to increase dramatically.
Mrs Balneaves, wife of an Alzheimer's sufferer adds: "As the wife and carer of an Alzheimer's patient, I understand fully how debilitating this disease is and how, in the majority of cases, it leaves sufferers requiring round-the-clock care and unable to interact fully with society.
"It causes untold suffering not only to the person with the disease, but also to their family and friends, and I can only welcome any research that can provide renewed hope of an improved quality of life for anyone touched by Alzheimer's."
The Glasgow Memory Clinic is based in a new £4m facility within the West of Scotland Science Park and is internationally recognised as a leading independent research organisation dedicated to finding better treatments for those with Memory Impairment, Alzheimer's disease and dementia.
Patients or caregivers interested in participating in the CONCERT trial are invited to contact the Glasgow Memory Clinic for information on eligibility and enrolment on 0141 948 0206 or http://www.glasgowmemoryclinic.com/. Further information is also available on the Concert study freephone number 0808 178 7959 or www.concertstudy.com.
About Concert
Concert (http://www.concertstudy.com/) is an international, randomised, double-blind, placebo-controlled study that will enrol approximately 1,050 patients with mild-to-moderate Alzheimer's disease at approximately 100 sites in western Europe, the United States, Australia and New Zealand. Patients on a stable dose of Aricept will be randomised to one of three treatment groups: dimebon 20 mg three times per day, dimebon 5 mg three times or placebo.
The primary endpoints are the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) and Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS - ADL), a measure of self-care and daily function. The Concert study is sponsored by Pfizer and Medivation, Inc.
About Dimebon
Dimebon (latrepirdine) is an investigational drug currently in Phase 3 development for the treatment of Alzheimer's disease and in clinical development for Huntington disease (HD). The comprehensive Phase 3 clinical development programme for Alzheimer's disease is evaluating the potential for dimebon to be used in broad applications including use alone, in combination with existing medications and in patients at all stages of the disease.
Dimebon has a unique mechanism of action, distinct from currently available treatments. In preclinical studies, dimebon has been shown to protect brain cells from damage and enhance brain survival, potentially stabilising and improving mitochondrial function. Mitochondria are critical to brain cell functioning as they are the primary source of energy for cells. Drugs that protect mitochondria or restore their function could potentially be a valuable treatment approach in AD.
Issued by Beattie Communications (www.beattiegroup.com) on behalf of Glasgow Memory Clinic (http://www.glasgowmemoryclinic.com/)
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