Study With Lu AF20513 in Patients With Mild Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) Due to AD

Alzheimer Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03819699
• Other study ID #: 18086A
• Status: Terminated
• Phase: Phase 1
• Start date: December 12, 2018
• Est. completion date: June 27, 2019

Study information

• Verified date: February 2020
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: June 27, 2019
• Est. primary completion date: June 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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-Aß 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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction

Intervention

Drug:
• Lu AF20513
Lu AF20513 suspension for injection

Biological:
• booster vaccine
booster vaccine (Cohort 2) - to be administered as per national recommendations

Locations

Country	Name	City	State
Finland	University of Eastern Finland, Brain Research Unit (FI002)	Kuopio
Finland	Clinical Research Services Turku Oy (FI001)	Turku
Sweden	Karolinska University Hospital, Huddinge (SE001)	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

Finland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC	Area under antibody titre curve (AUC) induced upon treatment with Lu AF20513	From Week 0 to Week 28
Primary	Cmax	maximum antibody titre (Cmax) induced upon treatment with Lu AF20513	From Week 0 to Week 28
Primary	Titre response	Any patients with antibody titre above the patient's baseline titre in either of the applied assays for antibody assessment	From Week 0 to Week 28
Secondary	Amyloid load	Change in composite cortical standard uptake volume ratio based on PET scans (amyloid PET-SUVR)	From baseline to week 84