NCT03611439

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable alzheimer-disease

Timeline
Completed

Started Oct 2013

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

October 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2015

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
Last Updated

August 2, 2018

Status Verified

July 1, 2018

Enrollment Period

2.2 years

First QC Date

July 17, 2018

Last Update Submit

July 26, 2018

Conditions

Alzheimer DiseaseAlzheimer Dementia

Outcome Measures

Primary Outcomes (3)

  • Change From Baseline Mini Mental State Exam (MMSE) Scores

    dementia questionnaire

    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

    Change from baseline ADCS-ADL at 12 months

  • Change From Baseline Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores

    dementia assessment

    Change from baseline CDR-SB at 12 months

Study Arms (2)

ReBuilder Actives

ACTIVE COMPARATOR

Subjects take one 650 mg capsule by mouth twice a day for 12 months.

Dietary Supplement: ReBuilder

ReBuilder Placebo

PLACEBO COMPARATOR

Subjects take one placebo capsule by mouth twice a day for 12 months.

Dietary Supplement: Placebo

Interventions

ReBuilderDIETARY_SUPPLEMENT

8-component botanical dietary supplement

Also known as: MX100A, Memex+
ReBuilder Actives
PlaceboDIETARY_SUPPLEMENT

Inactive Placebo Capsule

ReBuilder Placebo

Eligibility Criteria

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

You may qualify if:

  • Diagnosed mild or moderate Alzheimer's Disease

You may not qualify if:

  • History of heart disease
  • History of heart attack
  • History of cancer
  • History of stroke or transient ischemic attack

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
randomized, double blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized, placebo-controlled, double blind study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2018

First Posted

August 2, 2018

Study Start

October 1, 2013

Primary Completion

December 25, 2015

Study Completion

December 25, 2015

Last Updated

August 2, 2018

Record last verified: 2018-07