Neptune Krill Oil (NKO™) in Early Stage Alzheimer's Disease (MNEMOSYNE) (MNEMOSYNE)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00867828 |
Recruitment Status :
Completed
First Posted : March 24, 2009
Last Update Posted : October 3, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |

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 |

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. |
- 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 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00867828
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 |
Responsible Party: | NeuroBioPharm Inc. |
ClinicalTrials.gov Identifier: | NCT00867828 |
Obsolete Identifiers: | NCT00861289 |
Other Study ID Numbers: |
NBP-4209AD |
First Posted: | March 24, 2009 Key Record Dates |
Last Update Posted: | October 3, 2011 |
Last Verified: | September 2011 |
Decline of global cognitive function Neuropsychological Test Battery (NTB) Early stage Alzheimer's disease |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |