Male patients with mild to moderate Alzheimer´ Disease
Conditions
Interventions
Product Name: Ozarelix 65 mg
Product Code: ZEN-006-Z030
Pharmaceutical Form: Powder and solvent for solution for injection
CAS Number: 295 350 - 45
Current Sponsor code: ZEN-006, D-63153
Concentration
Sponsors
Zentaris GmbH
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male patient. 2. 55 years of age or older. 3. Diagnosis of probable AD, mild to moderate according to the NINCDS-ADRDA criteria, at least 6 months prior to screening. 4. Ongoing treatment with cholinesterase inhibitor and/or Memantine®, for 6 months or more and a stable dose at least for the last 3 months. 5. Mini Mental State Examination (MMSE) score of 17 to 26 (inclusive) at the screening visit. 6. Montgomery Asperg Depression Rating Scale (MADRS) score of 19 or less at the screening visit. 7. Available brain imaging study (CT scan, MRI or PET), at screening not older than one year; demonstrating absence of clinically significant lesion. 8. Adequate visual and auditory acuity to complete baseline assessments. Are the trial subjects under 18? no 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: 1. History of a systemic hypersensitivity reaction to drug or any of the excipients. 2. Evidence of significant cardiovascular, pulmonary, renal, hepatic, pancreatic, gastrointestinal, metabolic, endocrinological, neurological, psychiatric or other systemic disease or organ failure. 3. Chronic or clinically relevant acute infections. 4. Clinically relevant ECG abnormalities. 5. Clinically relevant abnormalities in clinical chemical, hematological or other laboratory parameters. 6. Abuse of alcohol and drugs. 7. Exposure to another investigational agent within the last month. 8. Significant neurological disease affecting the brain or psychiatric disease other than AD, such as major depression, schizophrenia, epilepsy, Parkinson's Disease, or stroke. 9. MADRS score of 19 or higher. 10. Recent – within last 60 days – or ongoing treatment with testosterone. 11. Recent – within last 90 days – or ongoing use of other medications known to affect serum gonadotropin concentrations, such as danazol or GnRH agonists like goserelin. 12. Recent - within last 60 days – change in the dosage of any drug that affects cognitive function, such as neuroleptics, antidepressants, anxiolytics, sedatives, hypnotics, anti-convulsants, centrally acting antihypertensive agents (clonidine and Aldomet) or other medications such as Vitamin E, nonsteroidal anti-inflammatory drugs, and statins. 13. Ongoing treatment with warfarin or anti-Parkinsonian medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess in male patients with mild to moderate Alzheimer’ Disease (AD) the potential of ozarelix to improve cognitive function as measured by Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) and the Bayer Activities daily Living scale (B-ADL).;Secondary Objective: 1. To assess the potential of ozarelix to slow the progression of AD. 2. To assess the impact of ozarelix on neurological and cognitive functions as assessed by different scales including Clinical Dementia rating and MMSE. 3. To assess the safety of the test drug. ;Primary end point(s): 1. cognitive: Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) sum score (a > 2.5 point improvement be considered a response to treatment) 2. functional: Bayer Activities of Daily Living scale (B-ADL) (a > 0.5 point improvement in the individual mean value will be considered a response to treatment) | — |
Countries
Germany
Outcome results
None listed