NL-OMON54794
Completed
Phase 2
A Pilot Electroencephalography (EEG) Study to Evaluate the Effect of CT1812 Treatment on Synaptic Activity in Subjects With Mild to Moderate Alzheimer*s Disease - Pilot Study of CT1812 in Mild to Moderate AD Using EEG
Julius Clinical0 sites16 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Alzheimer's Disease
- Sponsor
- Julius Clinical
- Enrollment
- 16
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants may be included in the study only if they meet all the following
- •1\) Women of non\-childbearing potential and men, aged 50 to 85 years, inclusive,
- •diagnosis of mild to moderate Probable Alzheimer\*s Disease Dementia, according
- •the NIA\-AA 2018 criteria and at least a 6\-month history of decline in cognitive
- •documented in the medical record.
- •i) Non\-childbearing potential for women is defined as postmenopausal (last
- •menses greater than 24 months) or undergone a documented bilateral tubal
- •ligation or hysterectomy. If last menses less than 24 months, a serum follicle
- •stimulating hormone (FSH) confirming post\-menopausal status will be
- •determined.
Exclusion Criteria
- •1\) Hospitalization (except for planned procedures) or change of chronic
- •concomitant medication within 1 month prior to screening
- •2\) Participants living in a continuous care nursing facility
- •3\) Contraindications to the MRI examination for any reason
- •4\) Screening MRI (or historical MRI, if applicable) of the brain indicative of
- •significant abnormality, including, but not limited to, prior hemorrhage or
- •infarct \> 1 cm3, \> 3 lacunar infarcts, cerebral contusion,
- •encephalomalacia, aneurysm, vascular malformation, subdural hematoma,
- •hydrocephalus, space\-occupying lesion
- •5\) Clinical or laboratory findings consistent with:
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A Pilot Clinical Study to evaluate the effect of CT1812 in subjects with Mild to Moderate Alzheimer’s Disease Using EEGMild to Moderate Alzheimer’s DiseaseMedDRA version: 20.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]EUCTR2019-003552-36-NLCognition Therapeutics, Inc.16
Recruiting
Not Applicable
Trauma Treatment Trial; 'Triple T'Posttraumatic Stress Disorder (PTSD)Mental Health - AnxietyACTRN12618001664235SW Service for the Treatment and Rehabilitation of Torture and Trauma Survivors80
Completed
Phase 2
Pilot Clinical Study of CT1812 in Mild to Moderate Alzheimer's Disease Using EEGAlzheimer DiseaseNCT04735536Cognition Therapeutics16
Not yet recruiting
Not Applicable
Analysis of the Electroencephalogram (EEG) during anesthesia using remimazolam and remifentanilKCT0006846Asan Medical Center30
Completed
Not Applicable
A study on quantitative electroencephalography of Alzheimer's disease patients in combination with donepezil and memantine and each single administratioAlzheimer's diseaseJPRN-UMIN000027818Kagawa University School of Medicine48