A Phase 2 clinical study to investigate the effects of BAN2401 in patients with early Alzheimer's Disease
- Conditions
- Mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease dementiaTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2012-002843-11-SE
- Lead Sponsor
- Eisai Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 800
Core
1.Meet NIA-AA core clinical criteria for MCI due to Alzheimer’s disease – intermediate likelihood
2.Subjects who have CDR score of 0.5 and Memory Box score of 0.5 or greater at Screening and Baseline
3.Subjects who report history of subjective memory decline with gradual onset and slow progression over the last 1 year before Screening; MUST be corroborated by an informant
4.Meet the NIA-AA core clinical criteria for probable Alzheimer’s disease dementia
5.Subjects who have CDR score of 0.5 to 1.0 and Memory Box score of 0.5 or greater at Screening and Baseline
Key Inclusion Criteria that must be met by ALL Subjects:
6.Subjects with objective impairment in episodic memory as indicated by at least 1 standard deviation below age-adjusted mean in the WMS-IV LMII, as follows:
a)=15 for age 50 to 64 years
b)=12 for age 65 to 69 years
c)=11 for age 70 to 74 years
d)=9 for age 75 to 79 years
e)=7 for age 80 to 90 years
7.Positive amyloid load as indicated by 1 of the following:
a.PET assessment
b.CSF assessment of Aß(1-42)
8.Male or female subjects aged between 50 and 90 years, inclusive
9.MMSE score equal to or greater than 22, and equal to or less than 30 at Screening and Baseline, except for the following countries, where MMSE score must be equal to or greater than 22 and equal to or less than 28 at Screening and Baseline: UK, ES, DE, SE, FR, and the NL
10.Body Mass Index >17 and <35 at Screening
11.Females must not be lactating or pregnant at Screening or Baseline All females will be considered to be of childbearing potential unless they are postmenopausal or have been sterilized surgically
12.Females of childbearing potential must not have had unprotected sexual intercourse within 30 days before study entry and must agree to use a highly effective method of contraception throughout the entire study period and for 35 days after study drug discontinuation. If currently abstinent, the subject must agree to use a double-barrier method as described above if she becomes sexually active during the study period or for 35 days after study drug discontinuation. Females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and must continue to use the same contraceptive during the study and for 35 days after study drug discontinuation.
13.Subjects who are receiving an AChEIs or memantine or both for AD must be on a stable dose for at least 12 weeks prior to Baseline. Treatment-naïve subjects for AD can be entered into the study. Unless otherwise stated, subjects must have been on stable doses of all other permitted concomitant medications for at least 4 weeks prior to Baseline. Use of memantine will not be allowed for Japanese subjects.
14.Must have an identified caregiver/informant The caregiver/informant must provide separate written informed consent. In addition, this person must be willing and able to provide follow-up information on the subject throughout the course of the study. This person must, in the opinion of the investigator, spend sufficient time with the subject on a regular basis such that the caregiver/informant can reliably fulfill the study requirements. A permanent caregiver/informant need not be living in the same residence with the subject. For such a caregiver/informant not residing with the subject, the investigator has to be satisfied that the subject can contact the caregiver/informant readily during the ti
Core
1. Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the subject’s AD
2. History of transient ischemic attacks, stroke, or seizures within 12 months of Screening
3. Any psychiatric diagnosis or symptoms, that could interfere with study procedures
4. GDS score =8 at Screening
5. Contraindications to MRI scanning, including cardiac pacemaker/ defibrillator, ferromagnetic metal implants
6. Evidence of other clinically significant lesions that could indicate a dementia diagnosis other than AD on MRI at Screening.
7. Other significant pathological findings on brain MRI at Screening, including but not limited to: more than 4 microhemorrhages (defined as 10 mm or less at the greatest diameter); a single macrohemorrhage greater than 10 mm at greatest diameter; an area of superficial siderosis; evidence of vasogenic edema; evidence of cerebral contusion, encephalomalacia, aneurysms, vascular malformations, or infective lesions; evidence of multiple lacunar infarcts or stroke involving a major vascular territory, severe small vessel, or white matter disease; space occupying lesions; or brain tumors [ (however, lesions diagnosed as meningiomas or arachnoid cysts and < 1cm at their greatest diameter need not be exclusionary]
8. Hypersensitivity to BAN2401 or any of the excipients, or to any monoclonal antibody treatment
9. Any immunological disease which is not adequately controlled, or which requires treatment with biologic drugs during the study
10. Subjects with a bleeding disorder not under adequate control
11. Subjects who have thyroid stimulating hormone above normal range. Other tests of thyroid function with results outside the normal range should only be exclusionary if they are considered clinically significant by the investigator. This applies to all subjects whether or not they are taking thyroid supplements.
12. Abnormally low serum Vitamin B12 levels.
13. A prolonged QT/QTc interval (QTc >450 ms) as demonstrated by a repeated electrocardiogram
14. Known to be HIV positive
15. Any other clinically significant abnormalities in physical examination, vital signs, laboratory tests or ECG at Screening or Baseline which in the opinion of the principal investigator (PI), require further investigation or treatment or which may interfere with study procedures or safety
16. Uncontrolled Type 1 or Type 2 diabetes mellitus
17. Uncontrolled hypertension with a history of blood pressure consistently above 165/100 mm Hg at Screening
18. History of uncontrolled cardiovascular disease within 6 months of Screening
19. Subjects with malignant neoplasms within 3 years of Screening (except for basal or squamous cell carcinoma in situ of the skin, or localized prostate cancer in male subjects). Subjects who had malignant neoplasms but who have had at least 3 years of documented uninterrupted remission before Screening need not be excluded.
20. Has a yes” answer to Columbia Suicide Severity Rating Scale suicidal ideation Type 4 or 5, or any suicidal behavior assessment within 6 months before Screening, at Screening, or at the Baseline Visit, or has been hospitalized or treated for suicidal behavior in the past 5 years before Screening
21. Known or suspected history of drug or alcohol abuse or dependence within 2 years before Screening or a positive urine drug test at Screening.
22. Any other medical conditions which are not stably controlled, or which in the opinion of the investiga
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