A Phase 1 Study to Evaluate the Safety and Tolerability of a Study Drug in Subjects with Early Alzheimer's Disease (AD)

M
Martin Farlow, MD

Primary Investigator

Overview

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.

Description

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. 

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Alzheimer's disease,early alzheimer's disease,alzheimer's,alzheimers,alzheimers disease,MCI,alzheimer's disease,alzheimers disease,alzheimers,alzheimer's,AD,MCI,mild cognitive impairment,dementia,early alzheimer's disease,early alzheimers disease
  • Age: Between 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
 
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

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)

Additional Information:
Participants will be paid for their participation.

Updated on 20 Nov 2022. Study ID: 1608086953

Interested in the study?

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