Neptune Krill Oil (NKO™) in Early Stage Alzheimer's Disease (MNEMOSYNE) (MNEMOSYNE)

Study Description

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Brief Summary:

The purpose of this study is to evaluate the efficacy of NKO™ softgels in reducing decline of global cognitive function as measured by the Neuropsychological Test Battery (NTB), in patients diagnosed with early stage Alzheimer's disease when compared to fish oil and a placebo after 24 weeks of treatment.

Condition or disease	Intervention/treatment	Phase
Early Onset Alzheimer Disease	Dietary Supplement: Neptune Krill Oil; Dietary Supplement: Fish Oil; Dietary Supplement: Placebo (soy oil)	Phase 4

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	175 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	Multi-Center, Double-Blind, Placebo-Controlled, Monotherapy Study of Neptune Krill Oil (NKO™) in Early Stage Alzheimer's Disease
Study Start Date :	May 2009
Actual Primary Completion Date :	July 2010
Actual Study Completion Date :	January 2011

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 1; Neptune Krill Oil(TM)softgels (1g QD). Each softgel of Neptune Krill Oil will provide approximately 150 mg EPA and 100 mg DHA.	Dietary Supplement: Neptune Krill Oil; Softgels 1g QD. Each softgel of Neptune Krill Oil will provide approximately 150 mg EPA and 100 mg DHA.
Active Comparator: 2; Fish oil softgels (1g QD). Each softgel of Fish Oil will provide approximately 150 mg EPA and 100 mg DHA.	Dietary Supplement: Fish Oil; Softgels 1g QD. Each softgel of Fish Oil will provide approximately 150 mg EPA and 100 mg DHA.
Placebo Comparator: 3; Placebo (soy oil) softgels (1g QD. The soy oil placebo will provide neither EPA nor DHA.	Dietary Supplement: Placebo (soy oil); Softgels 1g QD. The soy oil placebo will provide neither EPA nor DHA.

Outcome Measures

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Primary Outcome Measures :

1. The primary outcome measure will be the change in Neurological Test Battery between baseline and 24 weeks of treatment. [ Time Frame: Between baseline and 24 weeks of treatment ]

Secondary Outcome Measures :

1. Secondary outcome measures will include the change in DAD at 24 weeks of treatment, the change in NTB, GDS, DAD, and MMSE at 12 weeks.Safety and tolerability will be assessed by the incidence of treatment emergent adverse events. [ Time Frame: 24 week period ]

Eligibility Criteria

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Ages Eligible for Study:	50 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Patients aged 50 years or older.
• Patients with a clinical diagnosis of early stage Alzheimer's disease (NINCDS-ADRDA criteria) and with a Standardized Mini-Mental State Examination (MMSE) score of 20 - 26 inclusively and have demonstrated decline in their cognitive functions during the last six months as determined by the treating physicians.
• Patient has a score < 9 on the Hamilton Rating Scale for Depression (Ham-D) (Vida et al., 1994; Naarding et al., 2002).
• If on anti-depressant treatment and/or treatment for any other psychiatric condition the dose must have been stable for six months prior to randomization and should continue to be on the same stable dose for the entire treatment duration.
• Patient is not taking fish oil or Omega 3/6 supplement 2 weeks before screening visit.
• Patient is living at home or in a home for elderly persons.
• Patient has a responsible caregiver who is able to provide information about the patient's functional status.
• If on a cholinesterase inhibitor treatment the dose must have been stable for at least six months prior to randomization and should continue to be on the same stable dose for the entire treatment duration.
• If on any concomitant medication treatment the dose must have been stable for at least four months prior to randomization and should continue to be on the same stable dose for the entire treatment duration.
• Written informed consent is obtained from the patient or the legally accepted representative.

Exclusion criteria:

• Women who are pregnant or with childbearing potential and not willing to take adequate birth control measures.
• Severe or unstable diseases of any type, other than cognitive impairment, that may interfere with outcome evaluations. These include medical conditions expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical or mental status of the patient to a significant degree or put the patient at special risk.
• Intake of fish oil or Omega 3/6 supplement other than the study drug
• Patients are taking more than 400 mg vitamin E.
• The patient is not able to reliably take the study medication for the duration of the study (Patient compliance is < 60% after the 2-week run-in period).
• Patients with severe medical condition(s) that in the view of the treating physician prohibits participation in the study.
• Patients using any other investigational agent, or participating in another study within the last 30 days prior to the baseline visit.
• Patient with known allergy to fish, seafood or soy/soy-derived products.
• Patient diagnosed with coagulopathy or on anticoagulant therapy
• Patient subject to symptomatic hypoglycemia.
• Patient requires to be initiated on an anti-depressant medication and/or treatment for any other psychiatric condition prior to randomization.
• Patient requires to be initiated on a cholinesterase inhibitor treatment prior to randomization.

Contacts and Locations

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Locations

Canada, British Columbia
Surrey, British Columbia, Canada
Canada, Newfoundland and Labrador
Deer Lake, Newfoundland and Labrador, Canada
St. John's, Newfoundland and Labrador, Canada
Canada, Ontario
Cornwall, Ontario, Canada
Hamilton, Ontario, Canada
Hawkesbury, Ontario, Canada
Newmarket, Ontario, Canada
Ottawa, Ontario, Canada
Sarnia, Ontario, Canada
Thornhill, Ontario, Canada
Thunder Bay, Ontario, Canada
Canada, Quebec
Dollard Des Ormeaux, Quebec, Canada
Grand-Mere, Quebec, Canada
Montreal, Quebec, Canada

Sponsors and Collaborators

NeuroBioPharm Inc.

Neptune Technologies and Bioressources Inc.

More Information

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Responsible Party:	NeuroBioPharm Inc.
ClinicalTrials.gov Identifier:	NCT00867828 History of Changes
Obsolete Identifiers:	NCT00861289
Other Study ID Numbers:	NBP-4209AD
First Posted:	March 24, 2009
Last Update Posted:	October 3, 2011
Last Verified:	September 2011

Keywords provided by NeuroBioPharm Inc.:

Decline of global cognitive function; Neuropsychological Test Battery (NTB); Early stage Alzheimer's disease

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases	Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders