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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03307993
• Other study ID #: 17475A
• Status: Terminated
• Phase: Phase 1
• First received: September 26, 2017
• Last updated: April 3, 2018
• Start date: September 22, 2017
• Est. completion date: February 19, 2018

Study information

• Verified date: April 2018
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: February 19, 2018
• Est. primary completion date: February 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Idalopirdine
Idalopirdine 60-120 mg daily dose

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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