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TerminatedNCT03307993Updated Apr 4, 2018

Positron Emission Tomography (PET) Study in Patients With Alzheimer's Disease

A Phase 1 interventional study of Idalopirdine in Alzheimer's Disease, sponsored by H. Lundbeck A/S. Terminated at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2018-04-04.

Sponsored by H. Lundbeck A/S · Phase 1, Interventional, and Treatment

Why this study was terminated
The study was terminated for strategic reasons.
Phase
Phase 1
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
50 Years and older
Sex
All
01

Study summary

To investigate the brain receptor occupancy of idalopirdine in patients with Alzheimer's disease (AD)

02

Conditions studied

  • Alzheimer's Disease

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Keywords

  • Lu AE58054
03

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • The patient has probable AD diagnosed according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's disease and Related Disorders Association (NINCDS-ADRDA) criteria.
  • The patient has had a positive amyloid PET scan, which in the opinion of the principal investigator is consistent with a diagnosis of AD.
  • The patient has a Mini Mental State Examination (MMSE) score at screening of at least 15 and no greater than 22.
  • The patient has a knowledgeable and reliable caregiver who will accompany the patient to all clinic visits during the study and answer questions about the patient.
  • The patient is a man or woman of at least 50 years of age and has a body mass index (BMI) ≥ 18.5 kg/m2.

Exclusion criteria

Exclusion Criteria:

  • The patient has evidence of any clinically significant neurodegenerative disease, or other serious neurological disorders other than AD including but not limited to Lewy body dementia, fronto-temporal dementia, Parkinson's disease, Huntington's disease, major cortical stroke, major head trauma, primary or secondary cerebral neoplasia or systemic medical diseases that are, in the investigator's opinion, likely to affect central nervous system functioning and may influence the outcome or analysis of the scan results.
  • The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    Idalopirdine

    Idalopirdine 60 mg once daily for 10 day (up to 14 days possible), adjunct to donezepil (patients individualized maintenance dose) If high receptor occupancy cannot be verified, the receptor occupancy following a higher dose (up to 60 mg twice daily for 10-14 days) will be assessed in Cohort 2.

    Drug: Idalopirdine

Interventions

  • DrugIdalopirdine

    Idalopirdine 60-120 mg daily dose

    Also known as: Lu AE58054

05

What researchers measure

Primary outcomes

  1. 5-HT6 Receptor Occupancy (RO)

    RO in the region of interest will be calculated as 100 × (1 - BPND(treatment) / BPND(baseline)) where BPND is the binding potential

    Time frame: Treatment day 10 (24 hours post dose)

  2. Idalopirdine plasma concentration (CPET)

    CPET is the concentration at the time of PET scan, defined as (CprePET + CpostPET) / 2 (average of the pre- and post-PET scanning measurements).

    Time frame: Prior to and after PET scan on treatment day 10

06

Study locations

1 site
  • Johns Hopkins Hospital
    Baltimore, Maryland 21287, United States
07

Registry details

Key details

Study ID
NCT03307993
Lead sponsor
H. Lundbeck A/S
Responsible party
Sponsor
First posted
Oct 12, 2017
Start date
Sep 22, 2017
Primary completion
Feb 19, 2018
Completion
Feb 19, 2018
Last update
Apr 4, 2018

Study contacts

Email contact via H. Lundbeck A/S
study director · H. Lundbeck A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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