Suspended
ASAP3-Month, Single Site or Multi-Site, Double Blind, Randomized, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety Tolerability and Potential Effects of the Dietary Supplement Anatabloc(R) in Subjects With Alzheimer's Disease
What is being tested
Anatabloc(R)
+ Placebo
Dietary Supplement
Who is being recruted
Mental Disorders+6
+ Brain Diseases
+ Central Nervous System Diseases
From 65 to 90 Years
+8 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 2
Interventional
Study Start: August 2012
Summary
Principal SponsorRock Creek Pharmaceuticals, Inc.
Last updated: April 30, 2015
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2012
Actual date on which the first participant was enrolled.To explore whether dietary supplementation with a version of Anatabloc(R) exerts an effect on blood levels of amyloid beta (Aβ), or impacts global or functional measures of Alzheimer's Disease (AD) in subjects with mild to moderate AD.
Principal SponsorRock Creek Pharmaceuticals, Inc.
Last updated: April 30, 2015
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
85 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 65 to 90 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Mental DisordersBrain DiseasesCentral Nervous System DiseasesDementiaNervous System DiseasesNeurodegenerative DiseasesNeurocognitive DisordersTauopathiesAlzheimer Disease
Criteria
5 inclusion criteria required to participate
At least 65 years old
Have a diagnosis of probable AD or a concurrent diagnosis of probable AD and possible or probable vascular dementia
Otherwise stable medical history and general health
Score 16 or more on the Mini-Mental State Examination (MMSE)
Show More Criteria
3 exclusion criteria prevent from participating
Be a current smoker or smokeless tobacco user
Be currently taking any of the following medications: systemic (oral or injectable) glucocorticoids; interferon-alpha; anti-CD20 antibody (e.g., rituximab); or anti-CTLA-4 antibody (e.g., ipilimumab)
Have contra-indications, allergy, or sensitivity to the study products or their components
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorStudy product, as mint-flavored lozenge (3 mg anatabine per lozenge) to be taken 2-3 times each day
Group II
PlaceboPlacebo, as mint-flavored lozenge, to be taken 2-3 times each day
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
SuspendedOne Study Center