Alzheimer DiseaseNCT03611439
Effects of an 8 Component Botanical Supplement on Mild and Moderate Alzheimer's Patients
A study testing ReBuilder in people with Alzheimer Disease and Alzheimer Dementia, run by Genescient Corporation.
Trial summary
This placebo-controlled, double blind study evaluates the treatment effects of adding a multi-pathway botanical dietary supplement (ReBuilder) to the standard treatment regimens of subjects diagnosed with mild or moderate stage Alzheimer's Disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer Disease, Alzheimer Dementia
- What is being tested?
- ReBuilder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2013to 25 Dec 2015
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed mild or moderate Alzheimer's Disease
Who cannot join
- History of heart disease
- History of heart attack
- History of cancer
- History of stroke or transient ischemic attack
About this study
This placebo-controlled, double blind study evaluates the treatment effects of adding a multi-pathway botanical dietary supplement (ReBuilder) to the standard treatment regimens of subjects diagnosed with mild or moderate stage Alzheimer's Disease. The objective of the study is to determine if mild and moderate AD patients exhibit improved or stabilized cognitive function when this supplement is added to maximum tolerated doses of their standard treatments.
Read the detailed description
Currently, there is no treatment that can stop the progression of Alzheimer's Disease. The investigators in this study have used transgenic Drosophila melanogaster models and machine learning to develop an eight component botanical mixture (Geneaire™* ReBuilder™) that targets multiple genetic pathways involved in brain aging and dementia that are homologous between Drosophila and humans.
While beta-amyloid plaques and phosphorylated-tau tangles are diagnostic for AD, the cause(s) of their soluble precursors that kill neurons has not been determined. The majority of AD patients are diagnosed after 60 years of age. Many studies point to aging related processes like inflammation, neural vascular damage, neural stress, altered cell metabolism, inefficient cellular autophagy, microglial dysfunction, mitochondrial dysfunction, and poor diet as potential causal factors in the decline of brain function over the decades that precede an actual AD diagnosis. AD is a multifaceted pathology involving many biochemical pathways and thus a multifaceted therapeutic approach may prove beneficial.
The goal of this study was to test ReBuilder on human cognitive function. During the 12-month pilot study, the subjects were evaluated quarterly on the Mini Mental State Exam (MMSE), Alzheimer's Disease Cooperative Study's Activities of Daily Living (ADCS-ADL), and the Clinical Dementia Rating Sum of Boxes (CDR-SB).
- Conditions
- Alzheimer Disease, Alzheimer Dementia
- Being tested
- ReBuilder, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReBuilderDietary supplement
Also called MX100A, Memex+
8-component botanical dietary supplement
PlaceboDietary supplement
Inactive Placebo Capsule
| Study group | Role | What they receive |
|---|---|---|
| ReBuilder Actives | Active comparator | Subjects take one 650 mg capsule by mouth twice a day for 12 months. Receives: Dietary Supplement: ReBuilder |
| ReBuilder Placebo | Placebo comparator | Subjects take one placebo capsule by mouth twice a day for 12 months. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Mini Mental State Exam (MMSE) Scores
dementia questionnaire
Measured: Change from baseline MMSE at 12 months
Change From Baseline Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Scores
daily living activity questionnaire
Measured: Change from baseline ADCS-ADL at 12 months
Change From Baseline Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores
dementia assessment
Measured: Change from baseline CDR-SB at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start1 Oct 2013
- Primary completion25 Dec 2015
- Study completion25 Dec 2015
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, placebo-controlled, double blind study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genescient Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611439
- Sponsor's protocol ID
- Genescient
- Status last verified
- Jul 2018
- First submitted
- 17 Jul 2018
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an 8 Component Botanical Supplement on Mild and Moderate Alzheimer's Patients
- ClinicalTrials.gov ID
- NCT03611439
- Acronym / sponsor ID
- Genescient
- Conditions
- Alzheimer Disease, Alzheimer Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Genescient CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 25 Dec 2015 (actual)
- Study completion
- 25 Dec 2015 (actual)
- First posted
- 2 Aug 2018 (actual)
- 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.
This placebo-controlled, double blind study evaluates the treatment effects of adding a multi-pathway botanical dietary supplement (ReBuilder) to the standard treatment regimens of subjects diagnosed with mild or moderate stage Alzheimer's Disease. The objective of the study is to determine if mild and moderate AD patients exhibit improved or stabilized cognitive function when this supplement is added to maximum tolerated doses of their standard treatments.
Detailed description
Currently, there is no treatment that can stop the progression of Alzheimer's Disease. The investigators in this study have used transgenic Drosophila melanogaster models and machine learning to develop an eight component botanical mixture (Geneaire™* ReBuilder™) that targets multiple genetic pathways involved in brain aging and dementia that are homologous between Drosophila and humans.
While beta-amyloid plaques and phosphorylated-tau tangles are diagnostic for AD, the cause(s) of their soluble precursors that kill neurons has not been determined. The majority of AD patients are diagnosed after 60 years of age. Many studies point to aging related processes like inflammation, neural vascular damage, neural stress, altered cell metabolism, inefficient cellular autophagy, microglial dysfunction, mitochondrial dysfunction, and poor diet as potential causal factors in the decline of brain function over the decades that precede an actual AD diagnosis. AD is a multifaceted pathology involving many biochemical pathways and thus a multifaceted therapeutic approach may prove beneficial.
The goal of this study was to test ReBuilder on human cognitive function. During the 12-month pilot study, the subjects were evaluated quarterly on the Mini Mental State Exam (MMSE), Alzheimer's Disease Cooperative Study's Activities of Daily Living (ADCS-ADL), and the Clinical Dementia Rating Sum of Boxes (CDR-SB).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, placebo-controlled, double blind study
| Arm | Type | Receives |
|---|---|---|
| ReBuilder Actives | Active comparator | Dietary Supplement: ReBuilderSubjects take one 650 mg capsule by mouth twice a day for 12 months. |
| ReBuilder Placebo | Placebo comparator | Dietary Supplement: PlaceboSubjects take one placebo capsule by mouth twice a day for 12 months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed mild or moderate Alzheimer's Disease
Key exclusion criteria (4 listed)
- History of heart disease
- History of heart attack
- History of cancer
- History of stroke or transient ischemic attack
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 |
|---|---|---|
| ReBuilderAlso: MX100A, Memex+8-component botanical dietary supplement | Dietary supplement | ReBuilder Actives |
| PlaceboInactive Placebo Capsule | Dietary supplement | ReBuilder Placebo |
Primary outcome
Change From Baseline Mini Mental State Exam (MMSE) Scores
Time frame: Change from baseline MMSE at 12 months
dementia questionnaire
Change From Baseline Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Scores
Time frame: Change from baseline ADCS-ADL at 12 months
daily living activity questionnaire
Change From Baseline Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores
Time frame: Change from baseline CDR-SB at 12 months
dementia assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ReBuilder in people with Alzheimer Disease and Alzheimer Dementia, run by Genescient Corporation.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change From Baseline Mini Mental State Exam (MMSE) Scores (time frame: Change from baseline MMSE at 12 months). The study lists 3 primary outcomes in all. 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 2 Aug 2018.