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It appears that there has almost been a midnight hour last minute reprieve for Alzheimer’s patients and their families wishing to participate or at least to obtain Dimebon for patients and loved ones via the clinical trial route”A Phase 3 Study To Evaluate The Safety And Tolerability Of Dimebon Patients With Mild To Moderate Alzheimer’s Disease” is recruiting candidates and is underway
“This study is currently recruiting participants.”
This was only announced recently at Clinical Trials.gov and just verified by Pfizer itself
(Pfizer and Medivation had announced an agreement to co-develop and market Dimebon for treatment of Alzheimer’s Disease.
A Phase 3 Study To Evaluate The Safety And Tolerability Of Dimebon Patients With Mild To Moderate Alzheimer’s Disease
This study is currently recruiting participants.
Verified by Pfizer, June 2009
First Received: February 5, 2009 Last Updated: June 25, 2009 History of Changes
Sponsors and Collaborators: Pfizer
Medivation, Inc.
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00838110
triangle New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09 Purpose
This is a multi-center, randomized, double-blind placebo-controlled safety study conducted in 2 study cohorts. In Cohort 1, subjects with Alzheimer’s disease (n=250) will receive Dimebon 20 mg or placebo TID for 26 weeks. In Cohort 2 AD subjects (n=500) will be treated with Dimebon 20 mg or placebo TID for 12 weeks After completion of the randomized portion of the study, subjects in both Cohorts will have the opportunity to enroll in a Dimebon open label extension study.
Condition Intervention Phase
Alzheimer’s Disease Drug: Dimebon
Drug: Placebo Phase III
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety Study
Official Title: A Phase 3, Multi-Center, Randomized, Double-Blind Placebo-Controlled Study To Evaluate The Safety And Tolerability Of Dimebon (PF-01913539) For Up To 26-Weeks In Patients With Mild To Moderate Alzheimer’s Disease
Resource links provided by NLM:
Genetics Home Reference related topics: Alzheimer disease
MedlinePlus related topics: Alzheimer’s Disease
Drug Information available for: Dimebolin
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
* Adverse events [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
* ECG’s [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
* Vital Signs [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
* Clinical Chemistry / Hematology [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
Estimated Enrollment: 750
Study Start Date: February 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Dimebon 20 mg TID (Cohort 1): Experimental Drug: Dimebon
10 mg TID for week 1 followed by 20 mg TID through Week 26
Placebo TID (Cohort 1): Placebo Comparator Drug: Placebo
10 mg TID for week 1 followed by 20 mg TID through Week 26
Dimebon 20 mg TID (Cohort 2): Experimental Drug: Dimebon
10 mg TID for week 1 followed by 20 mg TID through Week 12
Placebo TID (Cohort 2): Placebo Comparator Drug: Placebo
20 mg matched Placebo (Cohort 2) 10 mg TID for week 1 followed by 20 mg TID through Week 12
triangle New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09 Eligibility
Ages Eligible for Study: 50 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
* Diagnosis of Alzheimer’s Disease.
* MMSE 12-26 inclusive.
* If on existing anti-dementia therapy, have been on a stable dose of anti-dementia therapy (cholinesterase inhibitors and/or memantine) for at least 60 days prior to dosing in study.
* If not taking existing anti-dementia therapy, have not received therapy with cholinesterase inhibitors and/or memantine within 60 days prior to dosing in this study.
Exclusion Criteria:
* Have major structural brain disease (e.g., ischemic infarcts, subdural hematoma, hemorrhage, hydrocephalus, brain tumors, multiple subcortical ischemic lesions, or a single lesion in a critical region [e.g., thalamus, hippocampus]).
* Have any major medical illness or unstable medical condition within six months of screening that may interfere with the patient’s ability to comply with study procedures and abide by study restrictions.
* Have not been on a stable dose of anti-dementia therapy for at least 60 days prior to dosing or intend to start anti-dementia therapy during the double blind portion of the study.
* Reside in a nursing home or assisted care facility with need for 24-hour care and supervision.
triangle New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09 Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00838110
Contacts
Contact: Pfizer CT.gov Call Center cb transparent l New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09us New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09space New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09space New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09arrow New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09space New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09space New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09space New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09space New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09space New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09space New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09space New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 091-800-718-1021cb transparent r New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09
plus New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09 Show 111 Study Locations
Sponsors and Collaborators
Pfizer
Medivation, Inc.
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
triangle New Additional Alzheimers Patients Wanted Medivation Dimebon Clinical Trial Study July 09 More Information
Additional Information:
To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site
No publications provided
Responsible Party: Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers: B1451027
Study First Received: February 5, 2009
Last Updated: June 25, 2009
ClinicalTrials.gov Identifier: NCT00838110 History of Changes
Health Authority: United States: Food and Drug Administration
Keywords provided by Pfizer:
Alzheimer’s Disease, Dimebon, Safety, Tolerability
Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases Brain Diseases
Dementia
Cognition Disorders
Delirium
Additional relevant MeSH terms:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia
ClinicalTrials.gov processed this record on June 30, 2009
http://www.dimebonalzheimers.com
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