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

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

Official Title
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Interventional, Open-label, Positron Emission Tomography (PET) Study Investigating the Brain Receptor Occupancy of Idalopirdine in Patients With Alzheimer's Disease

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: Idalopirdine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Idalopirdine<br>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<br>* Idalopirdine 60-120 mg daily dose<br>* Other names: Lu AE58054;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Treatment day 10 (24 hours post dose) | 
| 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). | Prior to and after PET scan on treatment day 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lu AE58054