Preview complete
The prescreener preview is complete. You may now close the preview.
AI-powered
A Phase 1 Study to Evaluate the Safety and Tolerability of a Study Drug in Subjects with Early Alzheimer's Disease (AD)
Study on Investigational Medication for Alzheimer's Disease
Recruiting
55 years - 85 years
All
Phase
1
1 Location
Brief description of study.
This study will test the safety and tolerability of an experimental study drug that may delay Alzheimer’s disease (AD) onset or slow the progression of possible AD-related damage due to protein build-up in the brain. Methods include measuring the amount of study drug and drug-related material in the cerebrospinal fluid (CSF, the fluid surrounding the brain and spinal cord) and blood, and measuring the effect of the study drug on the levels of certain proteins associated with AD in the blood and CSF.
Detailed description of study
The purpose of this study is to determine the safety and tolerability of multiple doses of Posiphen on subjects with early Alzheimer's Disease (AD) with up to 23-25 days of daily usage, and to implement a lumbar puncture (spinal tap) cerebrospinal fluid (CSF) study.
Participants will be paid for their participation.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Alzheimer's disease
-
Age: 55 years - 85 years
-
Gender: All
Inclusion Criteria
Diagnosis of amnestic MCI or probable mild AD
A minimum of 6 years of education of a good work history
Study partner who has frequent contact with the subject, and can accompany the subject to most visits to answer questions about the subject
Adequate visual and hearing ability
Good general health with no disease expected to interfere with the study
Must speak English fluently
Diagnosis of amnestic MCI or probable mild AD
A minimum of 6 years of education of a good work history
Study partner who has frequent contact with the subject, and can accompany the subject to most visits to answer questions about the subject
Adequate visual and hearing ability
Good general health with no disease expected to interfere with the study
Must speak English fluently
Female participants must be post-menopausal for at least 2 consecutive years or surgically sterile (bilateral tubal ligation, hysterectomy or bilateral oophorectomy) for at least 6 months prior to screening
Female participants will be given a urine pregnancy test at the screening visit for which they should test negative
Female participants will be given a urine pregnancy test at the screening visit for which they should test negative
Exclusion Criteria
History of psychiatric disorder such as schizophrenia, bipolar disorder or major depression
Other neurodegenerative diseases, including Parkinson's disease and Huntington's disease, or cerebral tumor
Dementia other than AD, such as Acquired Immunodeficiency Syndrome (AIDS), Creutzfeldt-Jakob disease (CJD), Lewy Bodies dementia (LBD), Cerebrovascular dementia (CVD), Progressive Supranuclear Palsy (PSP), or normal pressure hydrocephalus (NPH)
History of seizures
Current serious or unstable illness including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease or other conditions
Cancer or has had a malignant tumor within the past 3 years, except patients who underwent potentially curative therapy with no evidence of recurrence
Participation in another investigational clinical trial within 16 weeks prior to screening
Resides in a skilled nursing facility
History of lumbar spine surgery or chronic back pain (CLBP)
Updated on
19 Feb 2024.
Study ID: 1608086953
This study investigates the safety and tolerability of an investigational medication that may delay the onset or slow the progression of Alzheimer's disease (AD). Alzheimer's disease is a brain disorder that affects memory and thinking skills. The study will examine how the medication affects protein levels in the cerebrospinal fluid (CSF) and blood, which are associated with AD.
Participants will undergo procedures including lumbar punctures, also known as spinal taps, to collect cerebrospinal fluid. The study will measure the amount of the investigational medication in the CSF and blood to understand its effects on Alzheimer's-related proteins.
- Who can participate: Adults with mild cognitive impairment or probable mild Alzheimer's disease, who have at least 6 years of education and good general health, can participate. Female participants must be post-menopausal or surgically sterile, and all participants must speak English fluently and have a study partner.
- Study details: Participants will take multiple doses of an investigational medication over 23-25 days. A placebo, an inactive substance, may be used. Participants will undergo spinal taps to collect cerebrospinal fluid.
Pre-Screener
