NCT01320527

Brief Summary

Based on prior published pilot studies, the investigators have initiated a larger, multi-site placebo-controlled clinical trial with Alzheimer's disease (AD) patients and individuals diagnosed with Mild Cognitive Impairment (MCI), with the hopes of (1) confirming (or denying) the above promising clinical findings, and (2) determining whether or not our formulation can delay MCI "conversion" to AD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2008

Typical duration for phase_2

Geographic Reach
1 country

8 active sites

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

August 1, 2008

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 22, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

March 3, 2016

Status Verified

March 1, 2016

Enrollment Period

3.7 years

First QC Date

March 21, 2011

Last Update Submit

March 2, 2016

Conditions

Alzheimer's DiseaseMild Cognitive Impairment

Keywords

dietary supplementcognitionmoodAlzheimer's diseasememory loss

Outcome Measures

Primary Outcomes (1)

  • cognitive improvement or maintenance of cognitive performance

    Prior studies demonstrate cognitive improvement when treatment was initiated prior to or during mild-moderate Alzheimer's disease, and maintenance/ delayed decline in cognitive performance when treatment was initiated during moderate-severe Alzheimer's disease

    within 3 months of treatment

Secondary Outcomes (1)

  • behavioral/psychotic symptoms

    within 3 months after initiation of treatment

Study Arms (3)

Nutriceutical formulation

EXPERIMENTAL

Nutritional supplement

Dietary Supplement: Nutriceutical formulation

Placebo 1

PLACEBO COMPARATOR
Other: Placebo

Placebo 2

PLACEBO COMPARATOR
Other: Placebo

Interventions

Nutriceutical formulationDIETARY_SUPPLEMENT

Two pills that collectively contain: folic acid (400µg), Vitamin B12 (6µg), Vitamin E (as alpha-tocopherol; 30 IU), S-adenosylmethionine (SAM; 400mg), N-acetyl cysteine (NAC; 600mg) and Acetyl-L-carnitine (ALCAR; 500mg). Taken once daily for duration of study (1 year).

Also known as: MemoryXL
Nutriceutical formulation
PlaceboOTHER

A mixture of 6 vitamins and nutriceuticals

Placebo 1Placebo 2

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Alzheimer's disease or Mild Cognitive Impairment
  • must be able to swallow pills

You may not qualify if:

  • known or suspected bipolar disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Naples Medical Center

Naples, Florida, 34102, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Primary Care Cardiology Research

Ayer, Massachusetts, 01432, United States

Location

Rivercourt Residences

Groton, Massachusetts, 014590, United States

Location

Mary Immaculate Residential

Lawrence, Massachusetts, 01841, United States

Location

D'Youville Senior Care

Lowell, Massachusetts, 01854, United States

Location

Neurocognitive Institute

Mount Arlington, New Jersey, 07856, United States

Location

Advanced Memory Dynamics

Layton, Utah, 84040, United States

Location

Related Publications (3)

  • Mota SI, Pita I, Aguas R, Tagorti S, Virmani A, Pereira FC, Rego AC. Mechanistic perspectives on differential mitochondrial-based neuroprotective effects of several carnitine forms in Alzheimer's disease in vitro model. Arch Toxicol. 2021 Aug;95(8):2769-2784. doi: 10.1007/s00204-021-03104-1. Epub 2021 Jun 24.

    PMID: 34164711DERIVED

  • Remington R, Bechtel C, Larsen D, Samar A, Page R, Morrell C, Shea TB. Maintenance of Cognitive Performance and Mood for Individuals with Alzheimer's Disease Following Consumption of a Nutraceutical Formulation: A One-Year, Open-Label Study. J Alzheimers Dis. 2016;51(4):991-5. doi: 10.3233/JAD-151098.

    PMID: 26967219DERIVED

  • Remington R, Bechtel C, Larsen D, Samar A, Doshanjh L, Fishman P, Luo Y, Smyers K, Page R, Morrell C, Shea TB. A Phase II Randomized Clinical Trial of a Nutritional Formulation for Cognition and Mood in Alzheimer's Disease. J Alzheimers Dis. 2015;45(2):395-405. doi: 10.3233/JAD-142499.

    PMID: 25589719DERIVED

MeSH Terms

Conditions

Alzheimer DiseaseCognitive DysfunctionMemory Disorders

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ruth Remington, Ph.D.

    UMass Lowell, Lowell, MA 01854

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2011

First Posted

March 22, 2011

Study Start

August 1, 2008

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

March 3, 2016

Record last verified: 2016-03

Locations

US(8)