Posiphen for Alzheimer Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Columbia University Medical Center Sergievsky Center Taub Institute, New York, NY
Alzheimer Disease+1 More
Posiphen - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug may help treat early Alzheimer's disease.

See full description

Eligible Conditions

  • Alzheimer Disease
  • Alzheimer's Disease (AD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Alzheimer Disease

Study Objectives

This trial is evaluating whether Posiphen will improve 7 primary outcomes, 9 secondary outcomes, and 2 other outcomes in patients with Alzheimer Disease. Measurement will happen over the course of Up to 25 days.

Up to 25 days
Absolute synthesis and clearance rates
Assessment of cognitive effects
Assessment of mental status effects
Assessment of neuropsychiatric effects
Feasibility of CSF catheter study with SILK™ technology to evaluate %CSF samples with enough volume for testing
Feasibility of CSF catheter study with SILK™ technology to evaluate rates of enrollment
Feasibility of CSF catheter study with SILK™ technology to evaluate research satisfaction
Fractional synthesis rate of Aβ40 in CSF using the SILK™ technique with multiple doses of Posiphen
Fractional synthesis rates with normalized SILK curve sampling
Pharmacodynamic and PK-PD effects on CSF Alzheimer's Disease Biomarkers
Safety and Tolerability of multiple ascending doses of Posiphen: Reports of adverse events or study discontinuations
The levels of Posiphen and its metabolites will be determined in cerebrospinal fluid (CSF)
The levels of Posiphen and its metabolites will be determined in plasma
up to 25 days
AUC of Posiphen and its metabolites in plasma and CSF
Assessment of cognitive assessments
Concentration of soluble biomarkers of Alzheimer's disease in CSF
Fractional synthesis rate of Aβ40 in CSF using the SILK™ technique
Safety and Tolerability: Reports of adverse events or study discontinuations

Trial Safety

Safety Progress

1 of 3

Other trials for Alzheimer Disease

Trial Design

4 Treatment Groups

Low Dose
1 of 4
High Dose
1 of 4
Medium Dose
1 of 4
Placebo
1 of 4
Experimental Treatment
Non-Treatment Group

This trial requires 19 total participants across 4 different treatment groups

This trial involves 4 different treatments. Posiphen is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Low Dose
Drug
The study drug Posiphen dosage of 60mg is to be taken orally in divided doses, three times per day for a total 23-25 days.
High Dose
Drug
The study drug Posiphen dosage of 180mg is to be taken orally in divided doses, three times per day for a total 23-25 days.
Medium Dose
Drug
The study drug Posiphen dosage of 120mg is to be taken orally in divided doses, three times per day for a total 23-25 days.
Placebo
Drug
The Placebo comparator is to be taken orally in divided doses, three times per day for a total 23-25 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Posiphen
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 25 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 25 days for reporting.

Closest Location

Columbia University Medical Center Sergievsky Center Taub Institute - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Male or female aged 55 to 89 years (inclusive), in good health, no frailty.
Clinical profile consistent with MCI or mild AD, consistent with the core clinical criteria outlined in the NIA-AA Guidelines (2011).
MMSE score between 17 and 30 (inclusive).
You have a memory score of 0.5 or greater, or a CDR global score of 1.0. show original
Participant likely to tolerate all study procedures per PI judgment.
General cognition and functional performance sufficiently preserved that the subject can provide written informed consent.
You must have a minimum of 6 years of education or good work history. show original
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. show original
Female participants will be given a urine pregnancy test at the screening visit for which they should test negative. show original
Subjects will have a CSF Abeta42-Abeta40 ratio below 0.131 that is consistent with Alzheimers disease as measured via mass spectrometry by C2N. show original

Patient Q&A Section

Can alzheimer disease be cured?

"Although no medications were found to change the course of cognitive decline or the rate of disease acquisition, certain medications in the class of nonsteroidal antiandrogens might be able to reduce the occurrence of cerebrovascular episodes, but more research is needed before any conclusions can be made. In summary, while no medications were found to have a cure potential, medications might reduce the risk of developing Alzheimer's disease and the rate of progression of this disease." - Anonymous Online Contributor

Unverified Answer

What is alzheimer disease?

"Alzheimers disease (AD) is an incurable form of dementia. AD develops after age 60 years and almost always causes significant suffering to the patient and his/her family and close friends. This article details the condition of AD.\n" - Anonymous Online Contributor

Unverified Answer

What are the signs of alzheimer disease?

"Signs of Alzheimer's disease often include memory loss, which may include forgetting to visit one's doctor, and is most pronounced when the person is stressed, tired, or anxious." - Anonymous Online Contributor

Unverified Answer

What are common treatments for alzheimer disease?

"The findings provide a comprehensive coverage of the most commonly used clinical care for AD. The prevalence of antidepressant use, however, seems to be significantly underestimated compared to the general community. The prevalence of antidepressant use in patients receiving care in a psychiatric outpatient facility is higher than in general care." - Anonymous Online Contributor

Unverified Answer

How many people get alzheimer disease a year in the United States?

"The current data suggest that the number of cases of AD in the US is increasing at a reasonable pace of at least 19% per annum. The increase in the rate of progression is substantial, which raises the possibility of a large increase in the number of cases of AD in the U.S. in the future." - Anonymous Online Contributor

Unverified Answer

What causes alzheimer disease?

"Current research indicates that factors such as environment, lifestyle and genes combined with age influence one's risk of developing Alzheimer's disease. The cause of the initial disorder is unknown. The term AD is often used to emphasize the loss of functional brain neurons." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for alzheimer disease?

"Elderly individuals are the most likely to enroll in ALZR-III. Given our limited sample size, our results should not be overgeneralized to the elderly as a whole. Those individuals with cognitive impairment and those without family history may be more likely to consider ALZR-III." - Anonymous Online Contributor

Unverified Answer

How does posiphen work?

"Positiphen-treated subjects showed significantly fewer AD symptoms at the end of a two year open label treatment course for the onset of Alzheimer's disease compared with the control group. This treatment study with a double blinded placebo condition was designed to address the challenge of determining how posiphen reduces cognitive progression following Alzheimer's disease. A positive treatment effect could be predicted only up to 4 years from the time posiphen treatment commenced. More studies are needed to elucidate the mechanisms of action whereby posiphen reduces cognitive disease progression. Patients enrolled in the trial were screened and informed before accepting formal trial enrollment. All study personnel and patient database personnel received training in proper ethical conduct and privacy precautions." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of alzheimer disease?

"These data do not support the hypothesis that age (or, alternatively, a common modifier) is the principal cause of Alzheimer disease, and therefore the most effective prevention strategy would appear to be to screen older adults using some kind of blood test to detect, or to rule out, possible early pathology." - Anonymous Online Contributor

Unverified Answer

How serious can alzheimer disease be?

"Older patients with severe and even mild symptoms of dementia should have their risk of death and worsening dementia assessed closely. It may be safe to continue with treatments that seem to slow cognitive deterioration." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in posiphen for therapeutic use?

"The recent developments in posiphen for therapeutic use are encouraging in terms of a combination of antiplatelet therapy and anticoagulation for the treatment of the coexisting cardiovascular and neurological complications of Alzheimer's disease." - Anonymous Online Contributor

Unverified Answer

Is posiphen typically used in combination with any other treatments?

"When posiphen was used in combination with other treatments, participants reported significant improvement in a range of HRQOL domains. The addition of this treatment to other Alzheimer's disease therapies may be beneficial." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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