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

NCT03307993 | Terminated Phase 1 FDA Drug

• 1 other identifier: 17475A
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer's Disease

Keywords

Lu AE58054

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Idalopirdine

EXPERIMENTAL

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

Idalopirdine DRUG

Idalopirdine 60-120 mg daily dose

Also known as: Lu AE58054

Idalopirdine

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

(2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Email contact via H. Lundbeck A/S

  H. Lundbeck A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: October 12, 2017
• Study Start: September 22, 2017
• Primary Completion: February 19, 2018
• Study Completion: February 19, 2018
• Last Updated: April 4, 2018

Record last verified: 2018-04

Locations

US (1)