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

NCT02388152 | Terminated Phase 1 DMC

• 2 other identifiers: 16026A2014-001797-34
• Study Type: interventional
• Target: 50
• Locations: 3 countries
• Sites: 5

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

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability assessed by composite outcome measure consisting of absolute values and changes from baseline in: adverse events, clinical safety laboratory tests, vital signs

  ECGs, physical and neurological examination, suicidality assessment, Immunisation-Related Events (IRE) (selected from Brighton Collaboration guidelines) and magnetic resonance imaging (MRI) safety scans

  Baseline to week 96

• Antibody titre

  Baseline to week 96

Study Arms (4)

Lu AF20513, low dose (Cohort 1)

EXPERIMENTAL

10 Patients with mild Alzheimer's.

Drug: Lu AF20513, low dose

Lu AF20513, medium dose (Cohort 2)

EXPERIMENTAL

10 Patients with mild Alzheimer's.

Drug: Lu AF20513, medium dose

Lu AF20513, high dose (Cohort 3)

EXPERIMENTAL

15 Patients with mild Alzheimer's.

Drug: Lu AF20513, high dose

Lu AF20513, double high dose (Cohort 4)

EXPERIMENTAL

15 Patients with mild Alzheimer's.

Drug: Lu AF20513, double high dose

Interventions

Lu AF20513, low dose DRUG

Lu AF20513, low dose (Cohort 1)

Lu AF20513, medium dose DRUG

Lu AF20513, medium dose (Cohort 2)

Lu AF20513, high dose DRUG

Lu AF20513, high dose (Cohort 3)

Lu AF20513, double high dose DRUG

Lu AF20513, double high dose (Cohort 4)

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (5)

AT001

Vienna, Austria

Location

FI001

Turku, Finland

Location

SE002

Malmo, Sweden

Location

SE003

Mölndal, Sweden

Location

SE001

Stockholm, Sweden

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2015
• First Posted: March 13, 2015
• Study Start: March 1, 2015
• Primary Completion: July 4, 2019
• Study Completion: July 4, 2019
• Last Updated: November 29, 2019

Record last verified: 2019-11

Locations

AU (1); FI (1); SE (3)