- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00880412
A Study to Determine the Clinical Safety/Tolerability and Exploratory Efficacy of EHT 0202 as Adjunctive Therapy to Acetylcholinesterase Inhibitor in Mild to Moderate Alzheimer's Disease (EHT0202/002)
September 18, 2009 updated by: Exonhit
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
197
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ballainvilliers, France, 91160
- Hôpital Privé Les Magnolias
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Bergerac, France, 24100
- Cabinet Médical
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Bourg en Bresse, France, 01012
- Fleyriat Hospital
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Dijon, France, 21000
- Cabinet Médical
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Ivry sur Seine, France, 94026
- Charles Foix Hospital
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La Seyne sur Mer, France, 83500
- Cabinet Médical
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Lille, France, 59037
- Roger Salengro Hospital
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Limoges, France, 87042
- Dupuytren Hospital
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Magnanville, France, 78200
- Clinique Léopold Bellan
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Montpellier, France, 34070
- Cabinet Médical
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Montpellier, France, 34080
- Cabinet Médical 2
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Nantes, France, 44093
- CHU Nantes Hôpital Laennec
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Nice, France, 06000
- Cabinet Médical
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Nice, France, 06000
- Cabinet Médical 2
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Paris, France, 75013
- CHU Cochin Broca
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Rambouillet, France, 78120
- Cabinet Médical
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Rennes, France, 35033
- Chu Rennes
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Rodez, France, 12000
- Cabinet Médical
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Rueil Malmaison, France, 92500
- Cabinet Médical
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Saint Brieuc, France, 22000
- Cabinet Médical
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Toulon, France, 83000
- Cabinet Médical
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Toulouse, France, 31059
- Purpan-Casselardit Hospital - University of Toulouse
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ambulatory male or female patient, aged 60-90 years old included at screening, and living at home.
- Patient having a clinical diagnosis of probable AD according to National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
- Mild to moderate AD with a MMSE total score ≥ 12 and ≤ 24 at screening.
- Written informed consent obtained from the patient or, if appropriate, from legal representative according to local laws and regulations. The caregiver will also have to sign a specific informed consent form regarding his/her participation in the study.
- Patient treated for AD treatment with one AChEI (donepezil, galantamine, or rivastigmine), according to the recommended posology mentioned in the summary of product characteristics, for at least 3 months and with a stable dose for at least 2 months prior to screening. The dose should be kept unchanged throughout the study duration.
- Patient with a cerebral CT-scan or cerebral MRI compatible with AD diagnosis, with no brain lesions that may be related to another diagnosis and that could be responsible for the current patient's condition (ex, but not limited to, non-AD dementia, brain injury, brain tumour, stroke, normal pressure hydrocephalus,…). A cerebral CT-scan or cerebral MRI has to be performed and results have to be available prior patient's randomization if the results of the brain imagery performed to settle the AD diagnosis are not available in the patient's file. Brain imaging has also to be performed if considered necessary by the investigator, such as in case of emerging neurological symptoms or in case of worsening of existing neurological symptoms.
- Neurological exam without any particularities or without any specific focal signs likely to be related to other conditions than AD.
- No contra-indication to AChEI treatment and absence of significant adverse events considered to be related to AChEI treatment at screening and randomisation.
- Patient and patient's caregiver able to comply with study procedures, notably regarding the drug intake at the end of the meal which has to be supervised by the caregiver or another competent person.
Exclusion Criteria:
- Diagnosis of vascular dementia according to NINDS-AIREN criteria, or other non-AD dementia, or CNS pathology (including but not limited to brain injury, brain tumour, stroke, normal pressure hydrocephalus, Parkinson's disease, epilepsy,multiple sclerosis,…) that may be responsible for dementia.
- Clinically significant pathology and/or uncontrolled condition, including but not limited to cancer, infectious (like AIDS), gastro-intestinal, hepatic, renal, respiratory, endocrine(like diabetes mellitus, thyroiditis) pathology.
- History or current clinically significant psychiatric pathology (including but not limited to psychotic disorders, bipolar disorder, personality disorders) that may interfere with study assessments.
- Current major depressive disorder, either treated or not, associated with clinically significant symptoms.
- Low blood level of vitamin B12, TSH levels out of normal range at screening.
- Current forbidden medication intake or intake within 2 weeks prior to screening.
- Recent history (within the past year prior to inclusion) or current cardiovascular pathology and/or symptoms considered as clinically significant, including but not limited to angina pectoris, uncontrolled arrhythmia, significant ECG abnormalities. Lifetime history of heart failure, myocardial infarction, severe and/or uncontrolled angina pectoris,and/or ventricular arrhythmia disqualifies the patient.
- History or presence of clinically conditions that may interfere with product metabolism or with study assessments.
- Systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 90 mmHg at screening and/or randomisation.
- QTc interval (Bazett's correction) ≥ 430 msec for male and ≥ 450 msec for female at screening.
- Laboratory values (biochemistry, haematology, urinalysis) considered as clinically significant and/or that may interfere with study assessments, according to the investigator.
- ALAT, ASAT, ALP > 2.5 times the upper normal limit (UNL), total bilirubin > 1.5 UNL or history of significant liver pathology including hepatitis caused by drugs, HBV, HCV.
- BUN, creatinin > 1.5 UNL.
- Current or recent history of drug or alcohol abuse or dependence.
- Patient not registered at "Sécurité Sociale".
- Participation in another study within 1 month prior to screening and during the whole duration of the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: EHT 0202 40 mg bid
study treatment is given in addition to one acetylcholinesterase inhibitor (galantamine, rivastigmine or donepezil)
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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.
Other Names:
|
EXPERIMENTAL: EHT 0202 80 mg bid
study treatment is given in addition to one acetylcholinesterase inhibitor (galantamine, rivastigmine or donepezil)
|
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.
Other Names:
|
PLACEBO_COMPARATOR: placebo bid
study treatment is given in addition to one acetylcholinesterase inhibitor (galantamine, rivastigmine or donepezil)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
incidence/frequency and severity of adverse events, relation to treatment start and drug exposure, drop-out rate, including reason for withdrawal, clinical examination, change from screening of biological safety parameters, vital signs, ECG and weight.
Time Frame: all study visits
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all study visits
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessment of cognition (ADAS-Cog, Neuropsychological Test Battery, MMSE), patient's global functioning (CDR-SB,CGI), patient's behaviour (NPI), daily living activities (ADCS-ADL) and caregiver's burden. Population PK of EHT 0202 and PK/PD profile.
Time Frame: at the end of the 3-month study treatment period
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at the end of the 3-month study treatment period
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bruno Vellas, MD, Casselardit Hospital - University of Toulouse
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (ACTUAL)
June 1, 2009
Study Completion (ACTUAL)
August 1, 2009
Study Registration Dates
First Submitted
April 10, 2009
First Submitted That Met QC Criteria
April 10, 2009
First Posted (ESTIMATE)
April 13, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
September 21, 2009
Last Update Submitted That Met QC Criteria
September 18, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Alzheimer Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Enzyme Inhibitors
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Phosphodiesterase Inhibitors
- Etazolate
Other Study ID Numbers
- EHT0202/002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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