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Study With Lu AF87908 in Healthy Subjects and Patients With Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04149860
Recruitment Status : Recruiting
First Posted : November 4, 2019
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Brief Summary:
The purpose of this study is to investigate the safety of a single dose of Lu AF87908, how well it is tolerated and what the body does to the drug in healthy subjects and patients with Alzheimer's Disease

Condition or disease Intervention/treatment Phase
Healthy Alzheimer Disease Drug: Lu AF87908 Drug: Placebo Phase 1

Detailed Description:

The study will be divided into three parts: Part A, Part B and Part C.

Part A consists of up to 5 sequential cohorts (Cohorts A1 to A5):

-Cohorts A1 to A5: 8 healthy subjects per cohort (aiming for an equal number of men and women): 6 randomized to Lu AF87908 and 2 randomized to placebo.

Part B consists of up to 3 sequential cohorts (Cohorts B1 to B3):

-Cohorts B1 to B3: 4 healthy Japanese and 4 healthy Chinese subjects per cohort: 6 subjects randomized to Lu AF87908 and 2 subjects randomized to placebo.

Part C consists of up to 4 sequential cohorts (Cohort C1 to C4):

-Cohort C1 to C4: 8 patients with Alzheimer's disease per cohort: 6 randomized to Lu AF87908 and 2 randomized to placebo.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Interventional, Randomized, Double-blind, Placebo-controlled, Single-ascending-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Lu AF87908 in Healthy Subjects and Patients With Alzheimer's Disease
Actual Study Start Date : September 27, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part A
Cohorts A1-A5, 8 healthy subjects per cohort. Dose levels 1 - 5
Drug: Lu AF87908
Lu AF87908 concentrate for solution for infusion IV, single dose

Drug: Placebo
concentrate for solution for infusion IV

Experimental: Part B
Cohorts B1-B3, 8 healthy Japanese and Chinese subjects per cohort. Dose levels 3 - 5
Drug: Lu AF87908
Lu AF87908 concentrate for solution for infusion IV, single dose

Drug: Placebo
concentrate for solution for infusion IV

Experimental: Part C
Cohorts C1-C4, 8 subjects with Alzheimer's disease per cohort. Dose levels 3 - 6
Drug: Lu AF87908
Lu AF87908 concentrate for solution for infusion IV, single dose

Drug: Placebo
concentrate for solution for infusion IV




Primary Outcome Measures :
  1. Number of participants with treatment-emergent adverse events [ Time Frame: From Day 0 to Day 84 ]
    Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters and physical examination)

  2. AUC(0-t) of Lu AF87908 [ Time Frame: From Day 0 to Day 84 ]
    Area under the plasma concentration curve for Lu AF87908

  3. Cmax of Lu AF87908 [ Time Frame: From Day 0 to Day 84 ]
    Maximum observed plasma concentration for Lu AF87908

  4. Tmax Lu AF87908 [ Time Frame: From Day 0 to Day 84 ]
    Nominal time of occurence of Cmax of Lu AF97908 in plasma



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

Healthy subjects:

-Men and women ≥30 and ≤65 years of age with a body mass index (BMI) ≥18 and ≤32 kg/m2 and a minimum weight of 50 kg.

Patients with Alzheimer's disease:

  • Men and women with a clinical diagnosis of Alzheimer's disease, Stages 3-4 according to the FDA draft Guidance for Industry
  • MMSE 20-30, AND
  • CDR global score of 0.5 or 1.0.
  • Confirmed or determined (via amyloid PET scan) to be amyloid positive.
  • If on FDA approved Alzheimer's disease medication, the treatment has been stable for 4 months prior to Day 1.

    -≥50 years of age

  • BMI ≥18 and ≤34 kg/m2 and a minimum weight of 50 kg.

Exclusion criteria

  • Clinically relevant structural brain abnormality as assessed using MRI
  • Any past or current treatment with an anti-Abeta or anti-tau active vaccine
  • Any past or current treatment with a monoclonal antibody or anti-sense oligomer targeting tau within the last 6 months
  • Treatment with influenza or pneumonia vaccine within the last 30 days prior to dosing of IMP

Any other in- and exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04149860


Contacts
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Contact: Email contact via H. Lundbeck A/S +45 36301311 LundbeckClinicalTrials@Lundbeck.com

Locations
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United States, California
California Clinical Trials Medical Group Recruiting
Los Angeles, California, United States, 91206-4007
Contact: Email contact via H. Lundbeck A/S       LundbeckClinicalTrials@Lundbeck.com   
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com
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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT04149860    
Other Study ID Numbers: 18146A
First Posted: November 4, 2019    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders