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

NCT00867828 | Completed Phase 4

• 1 other identifier: NBP-4209AD
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 14

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.

Conditions

Early Onset Alzheimer Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure will be the change in Neurological Test Battery between baseline and 24 weeks of treatment.

  Between baseline and 24 weeks of treatment

Secondary Outcomes (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.

  24 week period

Study Arms (3)

1

EXPERIMENTAL

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

2

ACTIVE COMPARATOR

Fish oil softgels (1g QD). Each softgel of Fish Oil will provide approximately 150 mg EPA and 100 mg DHA.

Dietary Supplement: Fish Oil

3

PLACEBO COMPARATOR

Placebo (soy oil) softgels (1g QD. The soy oil placebo will provide neither EPA nor DHA.

Dietary Supplement: Placebo (soy oil)

Interventions

Neptune Krill Oil DIETARY_SUPPLEMENT

Softgels 1g QD. Each softgel of Neptune Krill Oil will provide approximately 150 mg EPA and 100 mg DHA.

1

Fish Oil DIETARY_SUPPLEMENT

Softgels 1g QD. Each softgel of Fish Oil will provide approximately 150 mg EPA and 100 mg DHA.

2

Placebo (soy oil) DIETARY_SUPPLEMENT

Softgels 1g QD. The soy oil placebo will provide neither EPA nor DHA.

3

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NeuroBioPharm Inc.: lead
• Neptune Technologies and Bioressources Inc.: collaborator

Study Sites (14)

Unknown Facility

Surrey, British Columbia, Canada

Location

Unknown Facility

Deer Lake, Newfoundland and Labrador, Canada

Location

Unknown Facility

St. John's, Newfoundland and Labrador, Canada

Location

Unknown Facility

Cornwall, Ontario, Canada

Location

Unknown Facility

Hamilton, Ontario, Canada

Location

Unknown Facility

Hawkesbury, Ontario, Canada

Location

Unknown Facility

Newmarket, Ontario, Canada

Location

Unknown Facility

Ottawa, Ontario, Canada

Location

Unknown Facility

Sarnia, Ontario, Canada

Location

Unknown Facility

Thornhill, Ontario, Canada

Location

Unknown Facility

Thunder Bay, Ontario, Canada

Location

Unknown Facility

Dollard-des-Ormeaux, Quebec, Canada

Location

Unknown Facility

Grand-Mère, Quebec, Canada

Location

Unknown Facility

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Fish Oils; Soybean Oil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Oils; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fats, Unsaturated; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2009
• First Posted: March 24, 2009
• Study Start: May 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: January 1, 2011
• Last Updated: October 3, 2011

Record last verified: 2011-09

Locations

CA (14)