A Phase 2 clinical study to investigate the effects of BAN2401 in patients with early Alzheimer's Disease

Phase 1

Conditions: Mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease dementia
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2012-002843-11-DE

Lead Sponsor: Eisai Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 800

Inclusion Criteria

Mild Cognitive Impairment due to Alzheimer’s Disease – Intermediate Likelihood:
1. Subjects meeting the National Institute of Aging – Alzheimer’s Association (NIA-AA) core clinical criteria for MCI due to Alzheimer’s disease - intermediate likelihood
2. Subjects who have a CDR score of 0.5 and a Memory Box score of 0.5 or greater at Screening and Baseline
3. Subjects who report a 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.Subjects who 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)
Subjects may consent to both the PET and CSF assessments, but need a
positive amyloid result in only one of the 2 procedures to confirm
eligibility . Subjects who initially consent for only one of the amyloid
screening assessments will only be allowed to subsequently consent for
the second assessment should the first assessment result be positive or
they have not yet been informed of the results of the first assessment.
Subjects who consent to Amyloid PET or CSF Amyloid are not required to
participate in the respective substudies.
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 f

Exclusion Criteria

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

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

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