Alzheimer DiseasePhase 2ASAPNCT01669876
Study to Evaluate Dietary Supplementation With a Version of Anatabloc(R) in Subjects With Alzheimer's Disease
A Phase 2 study testing Anatabloc(R) in people with Alzheimer Disease, run by Rock Creek Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Anatabloc(R)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Feb 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- At least 65 years old.
- Have a diagnosis of probable AD or a concurrent diagnosis of probable AD and possible or probable vascular dementia.
- Score 16 or more on the Mini-Mental State Examination (MMSE).
- Otherwise stable medical history and general health.
- Weigh between 45 kg and 120 kg inclusive.
Who cannot join
- Have contra-indications, allergy, or sensitivity to the study products or their components.
- 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).
- Be a current smoker or smokeless tobacco user.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 3-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
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.
- Conditions
- Alzheimer Disease
- Being tested
- Anatabloc(R), Placebo
- Keywords
- Randomized, Double-Blind, Dietary Supplements
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatabloc(R)Dietary supplement
Dietary supplement Anatabloc(R), as a mint-flavored lozenge, to be taken 2-3 times each day
PlaceboDietary supplement
Placebo, as a mint-flavored lozenge, to be taken 2-3 times each day
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement: Anatabloc(R) | Active comparator | Study product, as mint-flavored lozenge (3 mg anatabine per lozenge) to be taken 2-3 times each day Receives: Dietary Supplement: Anatabloc(R) |
| Placebo | Placebo comparator | Placebo, as mint-flavored lozenge, to be taken 2-3 times each day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects experiencing adverse effects when using the supplement
Collected data on the numbers and types of adverse effects among subject individuals with mild to moderate Alzheimer's disease (AD).
Measured: 3 months
Secondary outcomes (2)
Measured changes in blood markers of AD
Changes in blood levels of amyloid beta (Aβ)
Measured: 3 months
Changes in global or functional measures of AD in subjects during the course of the study
Changes in subject's scores in global and functional measures of AD during the course of the study
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2014
- Study completionFeb 2015
Why it stopped: Administrative status of active ingredient anatabine
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rock Creek Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Roskamp Institute Inc.
- Responsible party
- Sponsor
- Investigators
- A Keegan, MD, Principal investigator, Roskamp Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669876
- Sponsor's protocol ID
- RCP-009
- Acronym
- ASAP
- Status last verified
- Apr 2015
- First submitted
- 17 Aug 2012
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3-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
- ClinicalTrials.gov ID
- NCT01669876
- Acronym / sponsor ID
- ASAP / RCP-009
- Conditions
- Alzheimer Disease
- Keywords
- Randomized, Double-Blind, Dietary Supplements
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrative status of active ingredient anatabine
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Rock Creek Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Roskamp Institute Inc.
- Study start
- Aug 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 21 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement: Anatabloc(R) | Active comparator | Dietary Supplement: Anatabloc(R)Study product, as mint-flavored lozenge (3 mg anatabine per lozenge) to be taken 2-3 times each day |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo, as mint-flavored lozenge, to be taken 2-3 times each day |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- At least 65 years old.
- Have a diagnosis of probable AD or a concurrent diagnosis of probable AD and possible or probable vascular dementia.
- Score 16 or more on the Mini-Mental State Examination (MMSE).
- Otherwise stable medical history and general health.
- Weigh between 45 kg and 120 kg inclusive.
Key exclusion criteria (3 listed)
- Have contra-indications, allergy, or sensitivity to the study products or their components.
- 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).
- Be a current smoker or smokeless tobacco user.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anatabloc(R)Dietary supplement Anatabloc(R), as a mint-flavored lozenge, to be taken 2-3 times each day | Dietary supplement | Dietary Supplement: Anatabloc(R) |
| PlaceboPlacebo, as a mint-flavored lozenge, to be taken 2-3 times each day | Dietary supplement | Placebo |
Primary outcome
Number of subjects experiencing adverse effects when using the supplement
Time frame: 3 months
Collected data on the numbers and types of adverse effects among subject individuals with mild to moderate Alzheimer's disease (AD).
2 secondary outcomes
Measured changes in blood markers of AD
Time frame: 3 months
Changes in global or functional measures of AD in subjects during the course of the study
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Administrative status of active ingredient anatabine). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A Keegan, MD principal investigator
Roskamp Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anatabloc(R) in people with Alzheimer Disease, run by Rock Creek Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Administrative status of active ingredient anatabine). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects experiencing adverse effects when using the supplement (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2015.