Back to resultsPositron Emission Tomography (PET) Study in Patients With Alzheimer's Disease
Primary Purpose
Alzheimer's Disease
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Idalopirdine
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring Lu AE58054
Eligibility Criteria
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:
- 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.
Sites / Locations
- Johns Hopkins Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Idalopirdine
Arm Description
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.
Outcomes
Primary Outcome Measures
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
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03307993
Brief Title
Positron Emission Tomography (PET) Study in Patients With Alzheimer's Disease
Official Title
Interventional, Open-label, Positron Emission Tomography (PET) Study Investigating the Brain Receptor Occupancy of Idalopirdine in Patients With Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated for strategic reasons.
Study Start Date
September 22, 2017 (Actual)
Primary Completion Date
February 19, 2018 (Actual)
Study Completion Date
February 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate the brain receptor occupancy of idalopirdine in patients with Alzheimer's disease (AD)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Lu AE58054
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Idalopirdine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Idalopirdine
Other Intervention Name(s)
Lu AE58054
Intervention Description
Idalopirdine 60-120 mg daily dose
Primary Outcome Measure Information:
Title
5-HT6 Receptor Occupancy (RO)
Description
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)
Title
Idalopirdine plasma concentration (CPET)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
H. Lundbeck A/S
Official's Role
Study Director
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Positron Emission Tomography (PET) Study in Patients With Alzheimer's Disease
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