Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
1. Men and women aged ≥55 years.
2. Subject or subject's legally authorized representative is willing and able to provide
written informed consent.
3. Probable DLB and identified cognitive deficits, according to current consensus
criteria (McKeith et al, 2017), specifically one core clinical feature and a positive
DaTscan. If a negative DaTscan, but the subject has historical PSG-verified RBD, the
subject would also qualify.
4. MMSE score of 15-28, inclusive, during Screening.
5. Currently receiving cholinesterase inhibitor therapy, having received such therapy for
greater than 3 months and on a stable dose for at least 6 weeks at the time of
randomization. Except for reducing the dose for tolerability reasons, the dose of
cholinesterase inhibitor may not be modified during the study.
6. Normal or corrected eye sight and auditory abilities, sufficient to perform all
aspects of the cognitive and functional assessments.
7. No history of learning difficulties that may interfere with their ability to complete
the cognitive tests.
8. Must have reliable informant or caregiver.
Exclusion Criteria:
1. Diagnosis of any other ongoing central nervous system (CNS) condition other than DLB,
including, but not limited to, post-stroke dementia, vascular dementia, Alzheimer's
disease (AD), or Parkinson's disease (PD).
2. Suicidality, defined as active suicidal thoughts within 6 months before Screening or
at Baseline, defined as answering yes to items 4 or 5 on the C-SSRS, or history of
suicide attempt in previous 2 years, or, in the Investigator's opinion, at serious
risk of suicide.
3. Ongoing major and active psychiatric disorder and/or other concurrent medical
condition that, in the opinion of the Investigator, might compromise safety and/or
compliance with study requirements.
4. Diagnosis of alcohol or drug abuse within the previous 2 years.
5. Poorly controlled clinically significant medical illness, such as hypertension (blood
pressure >180 mmHg systolic or 100 mmHg diastolic); myocardial infarction within 6
months; uncompensated congestive heart failure or other significant cardiovascular,
pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine
disorders or other disease that would interfere with assessment of drug safety.
6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 × the upper
limit of normal (ULN), total bilirubin >1.5 × ULN, and/or International Normalized
Ratio (INR) >1.5.
7. Known human immunodeficiency virus, hepatitis B, or active hepatitis C virus
infection.
8. Participated in a study of an investigational drug less than 3 months or 5 half-lives
of an investigational drug, whichever is longer, before enrollment in this study.
9. History of previous neurosurgery to the brain.
10. If male with female partner(s) of child-bearing potential, unwilling or unable to
adhere to contraception requirements specified in the protocol.
11. If female who has not has not reached menopause >1 year previously or has not had a
hysterectomy or bilateral oophorectomy/salpingo-oophorectomy, has a positive pregnancy
test result during Screening and/or is unwilling or unable to adhere to the
contraception requirements specified in the protocol.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 3/15/2024. Questions regarding updates should be directed to the study team contact.