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Sponsored by: |
Exonhit Therapeutics |
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Information provided by: | Exonhit Therapeutics |
ClinicalTrials.gov Identifier: | NCT00880412 |
The objective of this 3-month study is to assess the safety and efficacy of EHT 0202 in addition to acetylcholinesterase inhibitor in patients suffering from Alzheimer's Disease.
Condition | Intervention | Phase |
---|---|---|
Alzheimer's Disease |
Drug: EHT 0202 etazolate Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Pilot, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre, Phase IIA Study to Determine the Clinical Safety/Tolerability and Exploratory Efficacy of EHT 0202 (40 and 80 mg Bid) as Adjunctive Therapy to Acetylcholinesterase Inhibitor Over a 3-Month Period in Ambulatory Patients Suffering From Mild to Moderate Alzheimer's Disease (EHT 0202/002 Protocol) |
Enrollment: | 197 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
EHT 0202 40 mg bid: Experimental
study treatment is given in addition to one acetylcholinesterase inhibitor (galantamine, rivastigmine or donepezil)
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Drug: EHT 0202 etazolate
In each arm, 2 capsules of study treatment (capsules of EHT0202 40mg and/or placebo) are taken twice a day during breakfast and dinner over a 3-month treatment period. There is non treatment adjustment.
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EHT 0202 80 mg bid: Experimental
study treatment is given in addition to one acetylcholinesterase inhibitor (galantamine, rivastigmine or donepezil)
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Drug: EHT 0202 etazolate
In each arm, 2 capsules of study treatment (capsules of EHT0202 40mg and/or placebo) are taken twice a day during breakfast and dinner over a 3-month treatment period. There is non treatment adjustment.
|
placebo bid: Placebo Comparator
study treatment is given in addition to one acetylcholinesterase inhibitor (galantamine, rivastigmine or donepezil)
|
Drug: Placebo
In each arm, 2 capsules of study treatment (capsules of EHT0202 40mg and/or placebo) are taken twice a day during breakfast and dinner over a 3-month treatment period. There is non treatment adjustment.
|
The aim of this pilot study is to assess the safety and tolerability profile of 2 doses of EHT 0202 (40 mg and 80 mg b.i.d) versus placebo in addition to a treatment with acetylcholinesterase inhibitor and its exploratory efficacy on cognition, behavior, activities of daily living, caregiver's burden and patient's global assessment, during a 3-month treatment period.
Ages Eligible for Study: | 60 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Purpan-Casselardit Hospital - University of Toulouse | |
Toulouse, France, 31059 | |
CHU Rennes | |
Rennes, France, 35033 | |
Charles Foix Hospital | |
Ivry sur Seine, France, 94026 | |
Fleyriat Hospital | |
Bourg en Bresse, France, 01012 | |
Dupuytren Hospital | |
Limoges, France, 87042 | |
Cabinet Médical | |
Montpellier, France, 34070 | |
Roger Salengro Hospital | |
Lille, France, 59037 | |
Cabinet Médical | |
Dijon, France, 21000 | |
CHU Cochin Broca | |
Paris, France, 75013 | |
Cabinet Médical | |
La Seyne sur Mer, France, 83500 | |
CHU Nantes Hôpital Laennec | |
Nantes, France, 44093 | |
Cabinet Médical 2 | |
Nice, France, 06000 | |
Cabinet Médical | |
Nice, France, 06000 | |
Cabinet Médical | |
Bergerac, France, 24100 | |
Hôpital Privé Les Magnolias | |
Ballainvilliers, France, 91160 | |
Cabinet Médical | |
Saint Brieuc, France, 22000 | |
Cabinet Médical 2 | |
Montpellier, France, 34080 | |
Clinique Léopold Bellan | |
Magnanville, France, 78200 | |
Cabinet Médical | |
Toulon, France, 83000 | |
Cabinet Médical | |
Rueil Malmaison, France, 92500 | |
Cabinet Médical | |
Rodez, France, 12000 | |
Cabinet Médical | |
Rambouillet, France, 78120 |
Principal Investigator: | Bruno Vellas, MD | Casselardit Hospital - University of Toulouse |
Responsible Party: | University of Toulouse - Purpan - Casselardit Hospital ( Professor Bruno Vellas, MD ) |
Study ID Numbers: | EHT0202/002 |
Study First Received: | April 10, 2009 |
Last Updated: | April 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00880412 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
safety efficacy Alzheimer's disease treatment |
phase II study cholinesterase inhibitor |
Neurotransmitter Agents Tranquilizing Agents Alzheimer Disease Psychotropic Drugs Central Nervous System Depressants Central Nervous System Diseases Antipsychotic Agents Brain Diseases Neurodegenerative Diseases |
Cholinergic Agents Cognition Disorders Cholinesterase Inhibitors Etazolate Phosphodiesterase Inhibitors Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Dementia Delirium |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Alzheimer Disease Nervous System Diseases Psychotropic Drugs Central Nervous System Depressants Central Nervous System Diseases Enzyme Inhibitors Antipsychotic Agents Cholinergic Agents |
Brain Diseases Neurodegenerative Diseases Pharmacologic Actions Cholinesterase Inhibitors Etazolate Phosphodiesterase Inhibitors Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Therapeutic Uses Dementia Tauopathies Central Nervous System Agents |