NCT04149860

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 participants and participants with Alzheimer's disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Sep 2019

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 27, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 4, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2023

Completed
Last Updated

August 4, 2023

Status Verified

August 1, 2023

Enrollment Period

3.8 years

First QC Date

October 31, 2019

Last Update Submit

August 3, 2023

Conditions

HealthyAlzheimer Disease

Outcome Measures

Primary Outcomes (4)

  • Number of Participants with Treatment Emergent Adverse Events

    Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters and physical examination)

    From Day 0 to Day 84

  • AUC(0-t) of Lu AF87908

    Area under the plasma concentration curve for Lu AF87908

    From Day 0 to Day 84

  • Cmax of Lu AF87908

    Maximum observed plasma concentration for Lu AF87908

    From Day 0 to Day 84

  • Tmax Lu AF87908

    Nominal time of occurrence of Cmax of Lu AF97908 in plasma

    From Day 0 to Day 84

Study Arms (3)

Part A: Lu AF87908 or Placebo

EXPERIMENTAL

Participants in Cohorts A1 to A6 will receive a single dose of either Lu AF87908 or matching placebo at specific dose levels on Day 1.

Drug: Lu AF87908Drug: Placebo

Part B: Lu AF87908 or Placebo

EXPERIMENTAL

Participants in Cohorts B1 to B3 will receive a single dose of either Lu AF87908 or matching placebo at specific dose levels on Day 1.

Drug: Lu AF87908Drug: Placebo

Part C: Lu AF87908 or Placebo

EXPERIMENTAL

Participants in Cohorts C1 and C4 will receive a single dose of either Lu AF87908 or matching placebo at specific dose levels on Day 1.

Drug: Lu AF87908Drug: Placebo

Interventions

Lu AF87908DRUG

Lu AF87908 concentrate for solution for intravenous (IV) infusion

Part A: Lu AF87908 or PlaceboPart B: Lu AF87908 or PlaceboPart C: Lu AF87908 or Placebo
PlaceboDRUG

Concentrate for solution for IV infusion

Part A: Lu AF87908 or PlaceboPart B: Lu AF87908 or PlaceboPart C: Lu AF87908 or Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy Participants:
  • Men and women ≥18 and ≤65 years of age with a body mass index (BMI) ≥18 and ≤32 kilograms (kg)/square meter (m\^2) and a minimum weight of 50 kg.
  • Participants with Alzheimer's disease:
  • Men and women with a clinical diagnosis of Alzheimer's disease, Stages 3-4 according to the FDA guidelines.
  • Mini-Mental State Examination (MMSE) of 15-30.
  • Clinical Dementia Scale (CDR) global score up to and including 2.0.
  • Confirmed or determined (via amyloid positron emission tomography \[PET\] 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 ≤40 kg/m\^2 and a minimum weight of 50 kg.

You may not qualify if:

  • Clinically relevant structural brain abnormality as assessed using magnetic resonance imaging (MRI).
  • Any past or current treatment with an anti-Abeta or anti-tau active vaccine.
  • Any past or current treatment with a monoclonal anti-tau antibody or a tau anti-sense oligomer within the last 6 months.
  • Treatment with covid-19, influenza or pneumonia vaccine within the last 30 days prior to dosing of investigational medicinal product (IMP).
  • Other eligibility criteria may apply.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

PAREXEL International

Glendale, California, 91206, United States

Location

Research Center of America

Hollywood, Florida, 33024, United States

Location

Panax Clinical Research

Miami, Florida, 33014, United States

Location

iResearch Atlanta LLC

Decatur, Georgia, 30030, United States

Location

Princeton Medical Institute

Princeton, New Jersey, 08540, United States

Location

Clinilabs, Inc.

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@Lundbeck.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2019

First Posted

November 4, 2019

Study Start

September 27, 2019

Primary Completion

July 19, 2023

Study Completion

July 19, 2023

Last Updated

August 4, 2023

Record last verified: 2023-08

Locations

US(6)