NCT02260167

Brief Summary

Treating with measures that may improve metabolic functioning of neurons in an integrated protocol

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 5, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 8, 2020

Status Verified

May 1, 2020

Enrollment Period

3.3 years

First QC Date

October 5, 2014

Last Update Submit

May 6, 2020

Conditions

Alzheimer's DiseaseDementia

Outcome Measures

Primary Outcomes (1)

  • Montreal Cognitive Assessment (MoCA)

    Looking to see what percent of patients show improvement

    6 months

Secondary Outcomes (2)

  • Mini Mental Status Exam (MMSE)

    6 months

  • Alzheimer's Disease Assessment Scale- Activities of Daily Living (ADAS-ADL)

    6 months

Study Arms (1)

Treatment with MIND

EXPERIMENTAL
Other: A mix of natural treatments and medications

Interventions

A mix of natural treatments and medicationsOTHER
Also known as: MIND Protocol
Treatment with MIND

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PAN

Kailua, Hawaii, 96740, United States

Location

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2014

First Posted

October 9, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

May 8, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)