Clinical trial NCT03819699: Study With Lu AF20513 in Patients With Mild Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) Due to AD
Official title: Interventional, Open-label, Multiple-immunisation Study of the Immunogenicity, Pharmacodynamics and Safety of Lu AF20513 in Patients With Mild Alzheimer's Disease or Mild Cognitive Impairment Due to Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2019-01-28
Enrollment: 3
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 two arms:

* dose regimen 2: 10 patients who will receive one administration of booster vaccine 4 weeks prior to the first IMP administration
* dose regimen 3: 10 patients who will not receive a booster vaccine

After the PA1, the study consists of the following periods:

* Screening Period - up to 12 weeks
* Priming period: 28 weeks, monthly dosing with Lu AF20513
* Maintenance Period - 56 weeks, quarterly dosing with Lu AF20513
* Follow-up Period - 4 weeks

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: AUC
timeFrame: From Week 0 to Week 28
measure: Cmax
timeFrame: From Week 0 to Week 28
measure: Titre response
timeFrame: From Week 0 to Week 28
Secondary outcomes:
measure: Amyloid load
timeFrame: From baseline to week 84
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: University of Eastern Finland, Brain Research Unit (FI002)
city: Turku
country: Finland
facility: Clinical Research Services Turku Oy (FI001)
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, Huddinge (SE001)
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: