Treatment of Alzheimer's and Dementia With the Metabolism, Infections, Nutrition, Drug Elimination (MIND) Protocol (MIND)

May 6, 2020 updated by: Practitioners Alliance Network

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment with MIND
Other: A mix of natural treatments and medications
Other Names:
  • MIND Protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment (MoCA)
Time Frame: 6 months
Looking to see what percent of patients show improvement
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Mini Mental Status Exam (MMSE)
Time Frame: 6 months
6 months
Alzheimer's Disease Assessment Scale- Activities of Daily Living (ADAS-ADL)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Practitioners Alliance Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2014

Primary Completion (ACTUAL)

December 1, 2017

Study Completion (ACTUAL)

December 1, 2017

Study Registration Dates

First Submitted

October 5, 2014

First Submitted That Met QC Criteria

October 8, 2014

First Posted (ESTIMATE)

October 9, 2014

Study Record Updates

Last Update Posted (ACTUAL)

May 8, 2020

Last Update Submitted That Met QC Criteria

May 6, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAN-ALZ002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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