Assessment of Inhibition of Brain MAO-B by EVT 301 after Repeated Dosing to Steady-state in Patients with Alzheimer’s Disease and in Elderly Control Subjects - Assessment of Inhibition of Brain MAO-B by EVT 301 after Repeated Dosing to Steady-state in Patients

• Conditions: Subjects with probable Alzheimer's Disease and healthy voulunteers

• Registration Number: EUCTR2006-001261-42-FI
• Lead Sponsor: Evotec NeuroSciences GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion criteria for elderly control subjects:
1. Male or naturally or surgically sterile female aged between 50- 80 years.
2. BMI (Body Mass Index) 18.0 – 32.0, body weight less than 100 kg.
3. Sufficient mental capacity to understand the nature of the trial and any potential risks of participating in it, and to provide voluntary Informed Consent. Ability to communicate satisfactorily with the investigator and to participate in the study, and to comply with the requirements of the entire trial.
4. Willingness to give written consent to participate after reading the Subject Information leaflet and the Consent Form, and after having the opportunity to discuss the trial with the investigator or his delegate.
5. Mini-Mental State Exam (MMSE) score of 27-30, inclusive.

Inclusion criteria for Alzheimer´s patients:
1. Male or naturally or surgically sterile female aged between 50- 80 years.
2. BMI 18.0 – 32.0, body weight less than 100 kg.
3. Onset of dementia between the ages of 45 and 80 years.
4. Does not require nursing home care. Subject lives with a spouse or other caregiver. Subject has a designated caregiver, either spouse or other caregiver, who will take responsibility for ensuring the administration of the study medication, the completion of protocol-stipulated assessments, either directly or through proxy, and is willing to sign the Consent Form. Caregiver may be a spouse, sibling, other next-of-kin or a person otherwise close to the subject or a legal representative.
5. Diagnosis of probable AD, based on the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer´s Disease and related Disorders Association criteria for this diagnosis (NINCDS/ADRDA criteria) and fulfills the DSM-IV criteria for dementia of the Alzheimer type.
6. Modified Hachinski Ischemic Scale score of 4 at the maximum.
7. Co-operative, able to ingest oral medication, willing to complete all aspects of the study, and capable of doing so either alone or with the help of a responsible caregiver.
8. Able to sign a written Informed Consent for participation in the study co-signed by the patient’s next of kin or caregiver.
9. Willingness to give written consent to participate after reading the Subject Information leaflet and the Consent Form, and after having the opportunity to discuss the trial with the investigator or his/her delegate and the caregiver.

Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria for elderly control subjects:
-Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer.
-History of Parkinson´s disease, any type of dementia, Alzheimer´s disease, Pick´s disease, Huntington´s disease, or Creutzfeldt-Jacob´s disease.
-Any active disease of the gastrointestinal system, liver, or kidneys .
-Presence of any acute or chronic illness or history of chronic illness not otherwise mentioned elsewhere and sufficient to invalidate the control subject´s participation in the trial or make it unnecessarily hazardous.
-Evidence of systemic infection.
-Current cognitive impairment due to drugs.
-Presence or history of severe adverse reaction to any drug.
-Concomitant medication that by the investigator´s judgement would interfere with the interpretation of the study assessments or constitute a hazard to the subject's safety
-Blood pressure and heart rate in seated position at the screening examination outside the ranges 90-160 mmHg systolic, 40-95 mmHg diastolic; resting heart rate outside of 50-90 beats/min.
-Positive test for hepatitis B, hepatitis C, HIV1 or HIV 2 at screening.
-History of cancer in the past 2 years, except for treated, non-recurrent skin cancer.
-Participation in a clinical trial with a pharmaceutical product within the previous 3 months
-Any other medical condition not previously mentioned that could be expected to put the subject at special risk.

Exclusion criteria for Alzheimer´s subjects:
-History or clinical evidence of stroke, normal pressure hydrocephalus, subdural hematoma, intracranial mass, current seizure disorder (seizures within 1 year of screening or under treatment with an anticonvulsant drug), significant head trauma within 5 years of dementia diagnosis that resulted in unconsciousness and hospitalisation, or dementia with an onset immediately following heart surgery or cardiac arrest.
-History of Parkinson´s disease, Pick´s disease, Huntington´s disease, or Creutzfeldt-Jacob´s disease.
-Clinically relevant abnormal medical history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer.
-History of abnormal liver function tests within one year.
-Evidence of systemic infection.
-Current cognitive impairment due to drugs.
-Clinically important thyroid hormone abnormalities detected within 1 year of study entry unless these laboratory abnormalities have been treated for at least 3 months, and dementia has progressed post-treatment and during the 6 months prior to enrolment.
-Clinically important folic acid or B?2 abnormalities detected within 1 year of study entry unless these laboratory abnormalities have been treated for at least 3 months, and dementia has progressed post-treatment and during the 6 months prior to enrolment.
-Blood pressure and heart rate in seated position at the screening examination outside the ranges 90-160 mmHg systolic, 40-95 mmHg diastolic; resting heart rate outside of 50-90 beats/min.
-Current evidence of pernicious anemia, history or current evidence of syphilitic brain disease or other chronic infections of the central nervous system.
-Any active disease of the gastrointestinal system, liver, or kidneys that could result in altered absorption, excess accumulation, or impaired metabolism

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified