Status:
TERMINATED
Study With Lu AF20513 in Patients With Mild Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) Due to AD
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50-85 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to study the effect of monthly dosing with a single dose of Lu AF20513, with and without booster vaccine, on antibody response.
Detailed Description
Cohort 1 encompasses 8 patients enrolled prior to the Protocol Amendment (PA) 1, dose regimen 1. Cohort 2 includes patients enrolled under the PA and will consist of 20 patients, randomly assigned to...
Eligibility Criteria
Inclusion
- The patient has a diagnosis of AD or Mild Cognitive Impairment (MCI) due to AD.
- The patient has evidence of an abnormal amyloid and tau status, consistent with AD, by means of a positive CSF test at screening
- The patient is aged ≥50 and ≤85 years. If a woman, the patient must be post-menopausal.
Exclusion
- The patient has participated in a clinical study where he/she has received passive or active anti-Aβ immunotherapy or other active immunisation for the treatment of AD.
- The patient has, in the investigator's opinion, evidence and/or history (clinically or on MRI) of any clinically significant neurodegenerative disease, serious neurological disorder, other intracranial or systemic diseases or conditions resulting in a definite or probable diagnosis of Major or Mild Neuro-Cognitive disorder other than AD, per DSM-5® criteria.
- Other in- and exclusion criteria may apply
Key Trial Info
Start Date :
December 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2019
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03819699
Start Date
December 12 2018
End Date
June 27 2019
Last Update
February 21 2020
Active Locations (3)
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1
University of Eastern Finland, Brain Research Unit (FI002)
Kuopio, Finland
2
Clinical Research Services Turku Oy (FI001)
Turku, Finland
3
Karolinska University Hospital, Huddinge (SE001)
Stockholm, Sweden