Treating Alzheimer's and Dementia With D-ribose | NCT02260141

Studies
Treating Alzheimer's and Dementia With D-ribose

NCT02260141

Sponsor

Practitioners Alliance Network

Status

Terminated

Last Update Posted

May 8, 2020Actual

Enrollment

3Actual

Phase

Not Applicable

Conditions

Alzheimers
Dementia

Interventions

d-ribose

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

unable to get adequate enrollment

Expanded Access Info

Start Date

Sep 2014Actual

Primary Completion Date

Oct 2017Actual

Completion Date

Oct 2017Actual

First Submitted Date

Oct 5, 2014

First Submission Date that Met QC Criteria

Oct 8, 2014

First Posted Date

Oct 9, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2020

Last Update Posted Date

May 8, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To study the effectiveness of d-ribose in treating Alzheimer's and Dementia

Detailed Description

Clinical experience and the pathophysiology of Alzheimer's, including neuronal insulin resistance, suggests that ribose improves clinical outcomes. This study will add ribose 5 gm 3 X day for 8 weeks to monitor outcomes in a pilot study.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment with d-ribose	Experimental	Treatment with ribose 5 gm TID	Dietary Supplement: d-ribose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
d-ribose	Dietary Supplement	giving ribose in those with a diagnosis of Alzheimer's and/or dementia	Treatment with d-ribose

Measure	Description	Time Frame
ADAS-ADL		2 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A diagnosis of Alzheimer's and/or dementia with a Mini Mental Status Exam ( 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 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
PAN		Kailua	Hawaii	96740	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003704	Dementia

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D019965	Neurocognitive Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012266	Ribose

Ancestor Terms

ID	Term
D010429	Pentoses
D009005	Monosaccharides
D000073893	Sugars
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided