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

NCT ID: NCT03307993

Last Updated: 2018-04-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-22
• Study Completion Date: 2018-02-19

Brief Summary

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

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Idalopirdine

Intervention Type: DRUG

Idalopirdine 60-120 mg daily dose

Interventions

Idalopirdine

Idalopirdine 60-120 mg daily dose

Intervention Type: DRUG

Other Intervention Names

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

H. Lundbeck A/S

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

17475A

Identifier Type: -

Identifier Source: org_study_id