Study to Evaluate the Safety and Tolerability of a New Drug Named Lu AF20513 in Patients With Mild Alzheimer's Disease

NCT ID: NCT02388152

Last Updated: 2019-11-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2019-07-04

Brief Summary

The purpose of this study is to determine if multiple immunizations with Lu AF20513 is tolerable and safe in patients with mild Alzheimer's disease.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lu AF20513, low dose (Cohort 1)

10 Patients with mild Alzheimer's.

Group Type: EXPERIMENTAL

Lu AF20513, low dose

Intervention Type: DRUG

Lu AF20513, medium dose (Cohort 2)

10 Patients with mild Alzheimer's.

Group Type: EXPERIMENTAL

Lu AF20513, medium dose

Intervention Type: DRUG

Lu AF20513, high dose (Cohort 3)

15 Patients with mild Alzheimer's.

Group Type: EXPERIMENTAL

Lu AF20513, high dose

Intervention Type: DRUG

Lu AF20513, double high dose (Cohort 4)

15 Patients with mild Alzheimer's.

Group Type: EXPERIMENTAL

Lu AF20513, double high dose

Intervention Type: DRUG

Interventions

Lu AF20513, low dose

Intervention Type: DRUG

Lu AF20513, medium dose

Intervention Type: DRUG

Lu AF20513, high dose

Intervention Type: DRUG

Lu AF20513, double high dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The patient has a diagnosis of probable Alzheimer's Disease (AD) consistent with the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
• The patient has a pattern of antibodies in cerebrospinal fluid (CSF) consistent with an amyloid plaque load
• The patient is a man or a woman, and between ≥60 and ≤85 years of age
• The patient has an MRI (performed within 3 months before screening) with results consistent with the diagnosis of probable AD
• The patient has a mild severity of dementia
• The patient has a knowledgeable and reliable caregiver who will be available and able to: accompany the patient to all clinical visits, monitor IRE after each immunization, and participate with the patient at all phone visits during the study AD
• Patients must have completed Part A before being eligible for continued immunisations in Part B

Exclusion Criteria

• The patient has evidence of mixed etiology of dementia (i.e. absence of other neurodegenerative, neuroinflammatory or cerebrovascular disease, or another neurological, mental or systemic disease or condition likely contributing to cognitive decline)
• The patient has clinical and radiological findings that fulfil the standards of the National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherché et l'Enseignement en Neurosciences (NINDS-AIREN) criteria for vascular dementia
• The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-5-TR) Axis I disorder other than AD; including amnestic disorders, delirium, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, post-traumatic stress disorder and/or cognitive disorder not otherwise specified, (note: patients may be included if treated with a stable dose of antidepressants for at least 2 months and not fulfilling DSM-5-TR criteria for depression at Screening)
• The patient's eligibility MRI scan (1.5T) shows findings that correspond to more than 4 brain micro haemorrhages
• The patient has extensive white matter lesions as shown on the screening MRI scan (1.5T)

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@lundbeck.com

Locations

AT001

Vienna, , Austria

FI001

Turku, , Finland

SE002

Malmo, , Sweden

SE003

Mölndal, , Sweden

SE001

Stockholm, , Sweden

Countries

Austria; Finland; Sweden

Other Identifiers

2014-001797-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

16026A

Identifier Type: -

Identifier Source: org_study_id