NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's Disease or Lewy Body Dementia (Cognition, Memory, Attention, Thinking)

Aptinyx

Status and phase

Active, not recruiting

Phase 2

Conditions

Mild Dementia

Mild Cognitive Impairment

Parkinson Disease

Lewy Body Disease

Treatments

Drug: NYX-458

Drug: Placebo Oral Capsule

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04148391

NYX-458-2006

Details and patient eligibility

About

A Study to Evaluate NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Associated With Parkinson's Disease or Prodromal or Manifest Lewy Body Dementia

Full description

The study will be a 16 to 18-week study, including a 2 to 4-week screening period, followed by a 12-week double-blind, randomized, placebo-controlled treatment Period, and a 2-week follow-up period. Subjects eligible for the study will be randomized to receive either NYX-458 or placebo.

Enrollment

99 patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Informed Consent
Diagnosis of Parkinson's disease and mild cognitive impairment or mild dementia OR diagnosis of mild cognitive impairment or mild dementia with Lewy bodies
Presence of subjective cognitive complaints by the patient
Verifiable impairment, as defined a CGI-S (Clinical Global Impression-Severity) score of at least 3 (mildly ill).
Score on the MoCA (Montreal Cognitive Assessment) between 15 and 25, inclusive.
Stable anti-parkinsonian regimen (if applicable)
Has a study partner who can accompany the subject at specified study visits

Exclusion criteria

Clinically meaningful motor complications
Current use of medications with primarily central nervous system activities
Other clinically significant medical histories that may interfere with completing the study.