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    Message Boards Forum Index    Alzheimer's or Other Dementias Under Age 65    Clinical trial for moderate to severe AD
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JAB
Posted
There is growing excitement about Dimebon, a drug that went through a very successful Phase II clinical trial, and is now in several Phase III trials and actively recruiting for others.

I just found out that there will be a new trial (up on the clinicaltrial.gov website but not yet recruiting) for AD patients with moderate to severe AD! It will be open to men and women ≥ 50 years of age with a diagnosis of Alzheimers disease, and a MMSE between 5 and 14 inclusive. Patients must be taking namenda, and cannot be taking cholinesterase inhibitors (have to have been off of them for at least two months.) Locations haven't been announced yet, but there is contact information for those of you who might be interested.

http://clinicaltrial.gov/ct2/show/NCT00912288

In the Phase II clinical trial, 70 percent of 183 patients with mild to moderate Alzheimer's who stayed on Dimebon for a year showed improvement in all five "domains" that were tested (cognition, activities of daily living, psychiatric symptoms, and global assessment). By contrast, placebo-treated patients deteriorated from baseline on all five endpoints. The trends at the 52-week point indicated that benefits may continue to increase over time. Some of the data indicate (although not conclusively) that dimebon treatment may actually result in disease modification.
 
Posts: 5109 | Registered: December 06, 2007Reply With QuoteEdit or Delete MessageReport This Post

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Hi JAB!

I found one of those clincal trials within 30 miles of my home. The trial is in Scotland Hospital, Scotland, PA. This trial allows people to continue using their current meds! I was excieted until my wife asked me if there would be any negative interaction with the meds I'm taking. The answer to that question is: probably not becaue they are in phase 2. But why take a chance! I'm not real bad right now because the drugs have altered my mood and allow me to concentrate somewhat better. I don't feel that the progression is moving too terribly fast and I firmly believe that a cure will be found within the next couple years.


Please visit my on-line support group for Early On-Set Alzheimer's at

http://youngerjourney.com

LATER...
 
Posts: 915 | Location?: HARRISBURG, PA | Registered: August 08, 2008Reply With QuoteEdit or Delete MessageReport This Post
JAB
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Ttom, are you talking about having found a Dimebon trial near you? That sounds like the trial I finally (finally, finally, finally!!!) got my husband into, yesterday.

Dimebon was used as an antihistamine in Russia for many years, and has a well-established safety profile. It has been very well-tolerated by patients in the trials so far. Pfizer has been taking things very slowly and carefully, first testing only AD patients who are not on any meds, then those who are only on Aricept, then those only on Namenda, and now finally allowing patients on both cholinesterase inhibitors and Namenda (yay!)

We've had opportunities to join other trials, but I didn't think the potential benefits were worth the risks. My husband has held pretty steady for four years now. I just have a queasy feeling we may be running out of luck, and this is by far the best IND I've seen.

There is, though, a "dimebon look-alike" called AVN-101 which is supposed to enter Phase II trials any day now. In theory, they say it has "many similarities and some promising improvements over Dimebon", such as a more favorable pharmacokinetic profile. You may want to keep tabs on that. It's being developed by Avineuro Pharmaceuticals Inc. here in San Diego.
 
Posts: 5109 | Registered: December 06, 2007Reply With QuoteEdit or Delete MessageReport This Post
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