A study to investigate the safety and tolerability of CNP520 in healthy elderly subjects
- Conditions
- Alzheimer's diseaseMedDRA version: 19.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2013-005576-18-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 124
1. Written informed consent must be obtained before any assessment is performed.
2. Male and postmenopausal female subjects aged 60 to 80 years, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests.
Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
Sexually active males must use a condom during intercourse while taking drug and for at least 3 months after stopping investigational medication and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.
3. Total MMSE score =25 for subjects with low educational attainment (12 or fewer years of education) or =27 for subjects with high educational attainment (13 or more years of education).
4. Ability to perform cognitive assessments (i.e. Cogstate battery as defined in the SOM).
5. Subjects must weigh at least 45 kg to participate in the study, and must have a body mass index (BMI) within the range of =18 to =34 kg/m2. BMI = Body weight (kg) / [Height (m2)].
6. Ability to communicate well with the investigator, to understand and comply with the requirements of the study.
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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
1. Use of other investigational drugs at the time of screening, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations.
2. History of hypersensitivity to BACE inhibitors.
3. Clinically significant ECG abnormalities as determined by single 12-lead ECGs and judged by the investigator.
4. Known family history or known presence of long QT syndrome or use of drugs known to prolong the QT interval unless it can be permanently discontinued from two weeks prior first dosing until study completion.
5. Clinically significant abnormal vital sign data as judged by the investigator.
6. History of hypersensitivity or known allergy to local anesthetics.
7. History of malignancy of any organ system within the past 5 years except for localized tumors not requiring systemic chemo- or radiotherapy such as localized basal cell carcinoma of the skin or in-situ cervical cancer.
8. Pregnant or nursing women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
9. Score yes” on item 4 or item 5 of the Suicidal Ideation section of the C-SSRS, if this ideation occurred in the past 6 months, or yes” on any item of the Suicidal Behavior section, except for the Non-Suicidal Self-Injurious Behavior”, if this behavior occurred in the past 2 years.
10. History or presence of any clinically significant disease of any major system organ class including cardiovascular, pulmonary, metabolic, endocrine, immunological or renal diseases which has not resolved within two weeks prior to initial dosing.
11. Heavy smokers.
12. Use of drugs known to be strong inhibitors or inducers of CYP3A4 and narrow-therapeutic index drugs known to be primarily metabolized by CYP2C or CYP3A isoenzymes within four weeks prior to initial dosing or within at least 5 half-lives prior to dosing, whichever longest.
13. Donation or loss of 450mL or more of blood within eight weeks prior to initial dosing, or longer if required by local regulation.
14. Plasma donation (>200mL) within 7 days prior to first dosing.
15. History within the last two years of autonomic dysfunction (e.g. recurrent episodes of fainting, palpitations etc.).
16. History within the past 2 years or presence of clinically significant neurological or psychiatric disorders including seizures, dementia, head trauma, schizophrenia, major depression, pseudotumor cerebri, bipolar disorder or demyelinating diseases.
17. Subject is mentally or legally incapacitated or has significant emotional problems in the opinion of the investigator.
18. Any abnormalities of laboratory values that are considered as clinically significant per investigator’s judgment.
19. Clinically significant thrombocytopenia or abnormal coagulation parameters including but not limited to prothrombin time and activated partial thromboplastin time.
20. Any medical condition that might lead to or is associated with any cognitive deficit including clinically relevant abnormality of thyroid function, vitamin B12 or folate deficiency, post-traumatic conditions, Huntington’s disease, Parkinson’s disease, Lyme disease or syphilis as reported by the subject.
21. History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays.
22. History or presence of conditions that may increase the susceptibility to drug-ind
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method