Back to resultsTreatment of Alzheimer's and Dementia With the Metabolism, Infections, Nutrition, Drug Elimination (MIND) Protocol (MIND)
Primary Purpose
Alzheimer's Disease, Dementia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
A mix of natural treatments and medications
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- PAN
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment with MIND
Arm Description
Outcomes
Primary Outcome Measures
Montreal Cognitive Assessment (MoCA)
Looking to see what percent of patients show improvement
Secondary Outcome Measures
Mini Mental Status Exam (MMSE)
Alzheimer's Disease Assessment Scale- Activities of Daily Living (ADAS-ADL)
Full Information
NCT ID
NCT02260167
First Posted
October 5, 2014
Last Updated
May 6, 2020
Sponsor
Practitioners Alliance Network
1. Study Identification
Unique Protocol Identification Number
NCT02260167
Brief Title
Treatment of Alzheimer's and Dementia With the Metabolism, Infections, Nutrition, Drug Elimination (MIND) Protocol
Acronym
MIND
Official Title
Effective Treatment of Alzheimer's and Dementia With the MIND Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Practitioners Alliance Network
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Dementia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment with MIND
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
A mix of natural treatments and medications
Other Intervention Name(s)
MIND Protocol
Primary Outcome Measure Information:
Title
Montreal Cognitive Assessment (MoCA)
Description
Looking to see what percent of patients show improvement
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Mini Mental Status Exam (MMSE)
Time Frame
6 months
Title
Alzheimer's Disease Assessment Scale- Activities of Daily Living (ADAS-ADL)
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Facility Information:
Facility Name
PAN
City
Kailua
State/Province
Hawaii
ZIP/Postal Code
96740
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Alzheimer's and Dementia With the Metabolism, Infections, Nutrition, Drug Elimination (MIND) Protocol
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