Alzheimer's DiseaseMINDNCT02260167
Treatment of Alzheimer's and Dementia With the Metabolism, Infections, Nutrition, Drug Elimination (MIND) Protocol
A study testing A mix of natural treatments and medications in people with Alzheimer's Disease and Dementia, run by Practitioners Alliance Network at 1 site in United States.
Trial summary
Treating with measures that may improve metabolic functioning of neurons in an integrated protocol Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer's Disease, Dementia
- What is being tested?
- A mix of natural treatments and medications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Dec 2017
- 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
- A diagnosis of Alzheimer's and/or dementia with an MMSE score over 12 or being ambulatory and able to travel outside the home with assistance.
- Must have a caregiver living with them.
Who cannot join
- Overt progressive and severe causes of secondary dementia such as metastatic brain cancers, or severe overt infectious encephalopathies or severe autoimmune illness.
- Also, severe life threatening illnesses which would make them unlikely to be alive after 6-12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effective Treatment of Alzheimer's and Dementia With the MIND Protocol
Treating with measures that may improve metabolic functioning of neurons in an integrated protocol
Read the detailed description
Most organ failure results in modest drops in function until over 50% of function is lost. At a certain point, even modest drops in physiologic activity result in dramatic drops in clinical function. Though less homogeneous than in other organs, clinical experience and the literature suggests a similar process occurs in the brain. The hypothesis is that by using an integrated protocol to, essentially, "tune up" neuronal function, a 5-10 % improvement in metabolic functioning may translate to significant improvement in clinical functioning. This tune-up will include "MIND":
M- Metabolism-- optimizing hormonal function I- Infections-- looking for and eliminating N- Nutritional and herbal support D- Drugs- Weaning subjects off unneeded medications
- Conditions
- Alzheimer's Disease, Dementia
- Being tested
- A mix of natural treatments and medications
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A mix of natural treatments and medicationsOther
Also called MIND Protocol
| Study group | Role | What they receive |
|---|---|---|
| Treatment with MIND | Experimental | Not described Receives: Other: A mix of natural treatments and medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MoCA)
Looking to see what percent of patients show improvement
Measured: 6 months
Secondary outcomes (2)
Mini Mental Status Exam (MMSE)
Measured: 6 months
Alzheimer's Disease Assessment Scale- Activities of Daily Living (ADAS-ADL)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Practitioners Alliance Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260167
- Sponsor's protocol ID
- PAN-ALZ002
- Acronym
- MIND
- Status last verified
- May 2020
- First submitted
- 5 Oct 2014
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Treatment of Alzheimer's and Dementia With the MIND Protocol
- ClinicalTrials.gov ID
- NCT02260167
- Acronym / sponsor ID
- MIND / PAN-ALZ002
- Conditions
- Alzheimer's Disease, Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Practitioners Alliance NetworkUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 9 Oct 2014 (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.
Treating with measures that may improve metabolic functioning of neurons in an integrated protocol
Detailed description
Most organ failure results in modest drops in function until over 50% of function is lost. At a certain point, even modest drops in physiologic activity result in dramatic drops in clinical function. Though less homogeneous than in other organs, clinical experience and the literature suggests a similar process occurs in the brain. The hypothesis is that by using an integrated protocol to, essentially, "tune up" neuronal function, a 5-10 % improvement in metabolic functioning may translate to significant improvement in clinical functioning. This tune-up will include "MIND":
M- Metabolism-- optimizing hormonal function I- Infections-- looking for and eliminating N- Nutritional and herbal support D- Drugs- Weaning subjects off unneeded medications
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with MIND | Experimental | Other: A mix of natural treatments and medications |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- A diagnosis of Alzheimer's and/or dementia with an MMSE score over 12 or being ambulatory and able to travel outside the home with assistance.
- Must have a caregiver living with them.
Key exclusion criteria (2 listed)
- Overt progressive and severe causes of secondary dementia such as metastatic brain cancers, or severe overt infectious encephalopathies or severe autoimmune illness.
- Also, severe life threatening illnesses which would make them unlikely to be alive after 6-12 months
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 |
|---|---|---|
| A mix of natural treatments and medicationsAlso: MIND Protocol | Other | Treatment with MIND |
Primary outcome
Montreal Cognitive Assessment (MoCA)
Time frame: 6 months
Looking to see what percent of patients show improvement
2 secondary outcomes
Mini Mental Status Exam (MMSE)
Time frame: 6 months
Alzheimer's Disease Assessment Scale- Activities of Daily Living (ADAS-ADL)
Time frame: 6 months
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 8 May 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A mix of natural treatments and medications in people with Alzheimer's Disease and Dementia, run by Practitioners Alliance Network 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 2 inclusion and 2 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 8 May 2020. 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. 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?
Montreal Cognitive Assessment (MoCA) (time frame: 6 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 8 May 2020.