Alzheimer's Disease Education and Referral Center

ELND005 for Agitation and Aggression in Alzheimer's Disease

Overall Status:

Recruiting

Brief Description:

The purpose of this study is to determine whether the experimental drug ELND005 is effective in treating symptoms of agitation and aggression in people with Alzheimer's disease.

Patient Qualifications:

Min Age	Max Age	Gender	Healthy Volunteers
55 Years	85 Years	Both	No

Inclusion Criteria:

Diagnosis of probable Alzheimer's disease (MMSE score of 10 to 21 at screening)
Clinically significant agitation/aggression, defined as Neuropsychiatric Inventory (NPI) agitation/aggression subscore of ≥4, with a severity score of ≥2 at both screening and baseline visits
No response or suboptimal response to standard nonpharmacological interventions

Exclusion Criteria:

Agitation/aggression attributable to medications, environmental conditions, or an active medical or psychiatric condition
Current diagnosis of major depressive disorder
Symptoms of psychosis (delusion or hallucinations) that require treatment with antipsychotics or psychiatric hospitalization
Treated with oral antipsychotic medications within 2 weeks prior to screening; treated with depot preparations of an antipsychotic within 3 months prior to screening
MRI scan abnormalities at screening that can be attributed to diseases or processes other than Alzheimer's disease

Detailed Description:

The experimental drug being tested in this Phase II study, ELDN005, is a small molecule that has been found to block the accumulation of beta-amyloid oligomers and possibly protect against cognitive decline. Known generically as scyllo-inositol, it is a naturally occurring plant sugar alcohol found in the coconut palm, oak bark, and other plants.

Central Contact Information:

For more information about this trial or its study sites, please contact Barbara Gaunce at 910-558-4645.

Locations:

Map Marker	City	State	Zip Code	Status	Primary Contact
Geolocation is 33.5075555, -86.8093239	Birmingham	Alabama	35294	Recruiting	Name: Phone:
Geolocation is 33.4528292, -112.0685027	Phoenix	Arizona	85004	Recruiting	Name: Phone:
Geolocation is 33.4636012, -112.0535987	Phoenix	Arizona	85006	Recruiting	Name: Phone:
Geolocation is 33.612697, -112.280129	Sun City	Arizona	85351	Recruiting	Name: Phone:
Geolocation is 34.1583323, -118.5155901	Encino	California	91316	Recruiting	Name: Phone:
Geolocation is 33.090285, -117.0499859	Escondido	California	92025	Recruiting	Name: Phone:
Geolocation is 36.8179331, -119.7599761	Fresno	California	93710	Recruiting	Name: Phone:
Geolocation is 33.8065036, -118.1912538	Long Beach	California	90806	Recruiting	Name: Phone:
Geolocation is 33.8030716, -118.0725641	Los Alamitos	California	90720	Recruiting	Name: Phone:
Geolocation is 33.615828, -117.9307584	Newport Beach	California	92663	Recruiting	Name: Phone:
Geolocation is 33.7463915, -117.8604472	Santa Ana	California	92701	Recruiting	Name: Phone:
Geolocation is 41.1339818, -73.4062342	Norwalk	Connecticut	06851	Recruiting	Name: Phone:
Geolocation is 41.5242649, -72.0759105	Norwich	Connecticut	06360	Recruiting	Name: Phone:
Geolocation is 26.5909025, -80.1008762	Atlantis	Florida	33462	Recruiting	Name: Phone:
Geolocation is 26.2778269, -80.109357	Deerfield Beach	Florida	33064	Recruiting	Name: Phone:
Geolocation is 26.4647478, -80.109357	Delray Beach	Florida	33445	Recruiting	Name: Phone:
Geolocation is 26.5907805, -80.2432839	Lake Worth	Florida	33449	Recruiting	Name: Phone:
Geolocation is 25.8207159, -80.1819268	Miami	Florida	33137	Recruiting	Name: Phone:
Geolocation is 26.180392, -80.1372757	Oakland Park	Florida	33334	Recruiting	Name: Phone:
Geolocation is 28.5085825, -81.3564411	Orlando	Florida	32806	Recruiting	Name: Phone:
Geolocation is 29.2858129, -81.0558894	Ormond Beach	Florida	32174	Recruiting	Name: Phone:
Geolocation is 26.8598894, -80.0870155	Palm Beach Gardens	Florida	33410	Recruiting	Name: Phone:
Geolocation is 26.98699, -82.09518	Port Charlotte	Florida	33952	Recruiting	Name: Phone:
Geolocation is 27.4081935, -82.5294065	Sarasota	Florida	34243	Recruiting	Name: Phone:
Geolocation is 26.17785, -80.2711588	Sunrise	Florida	33351	Recruiting	Name: Phone:
Geolocation is 32.5371089, -84.9297206	Columbus	Georgia	31909	Recruiting	Name: Phone:
Geolocation is 31.9708128, -81.1586515	Savannah	Georgia	31419	Recruiting	Name: Phone:
Geolocation is 42.0039178, -87.9703461	Elk Grove Village	Illinois	60007	Recruiting	Name: Phone:
Geolocation is 39.8264081, -89.6157473	Springfield	Illinois	62702	Recruiting	Name: Phone:
Geolocation is 38.0103355, -84.5327038	Lexington	Kentucky	40503	Recruiting	Name: Phone:
Geolocation is 44.8, -68.78	Bangor	Maine	04402	Recruiting	Name: Phone:
Geolocation is 38.7742826, -76.0763305	Easton	Maryland	21601	Recruiting	Name: Phone:
Geolocation is 42.452303, -71.1369959	Winchester	Massachusetts	01890	Recruiting	Name: Phone:
Geolocation is 31.3271189, -89.2903392	Hattiesburg	Mississippi	39401	Recruiting	Name: Phone:
Geolocation is 41.2552541, -95.9796225	Omaha	Nebraska	68198	Recruiting	Name: Phone:
Geolocation is 40.3572976, -74.6672226	Princeton	New Jersey	08540	Recruiting	Name: Phone:
Geolocation is 43.0915814, -77.6421577	Rochester	New York	14623	Recruiting	Name: Phone:
Geolocation is 43.1301942, -77.6020569	Rochester	New York	14620	Recruiting	Name: Phone:
Geolocation is 35.1811188, -80.8488498	Charlotte	North Carolina	28209	Recruiting	Name: Phone:
Geolocation is 35.8019142, -78.6875364	Raleigh	North Carolina	27607	Recruiting	Name: Phone:
Geolocation is 34.2257255, -77.9447102	Wilmington	North Carolina	28401	Recruiting	Name: Phone:
Geolocation is 36.0564654, -80.3324514	Winston-Salem	North Carolina	27103	Recruiting	Name: Phone:
Geolocation is 35.5135639, -97.5788975	Oklahoma City	Oklahoma	73112	Recruiting	Name: Phone:
Geolocation is 40.1313817, -75.1370254	Abington	Pennsylvania	19001	Recruiting	Name: Phone:
Geolocation is 40.0959438, -75.1251743	Jenkintown	Pennsylvania	19046	Recruiting	Name: Phone:
Geolocation is 40.121497, -75.3399048	Norristown	Pennsylvania	19401	Recruiting	Name: Phone:
Geolocation is 40.4379259, -79.9556424	Pittsburgh	Pennsylvania	15213	Recruiting	Name: Phone:
Geolocation is 41.8164902, -71.3646236	East Providence	Rhode Island	02914	Recruiting	Name: Phone:
Geolocation is 32.379494, -80.6937177	Port Royal	South Carolina	29935	Recruiting	Name: Phone:
Geolocation is 32.5898577, -96.8569451	DeSoto	Texas	75115	Recruiting	Name: Phone:
Geolocation is 37.5803608, -77.4874049	Richmond	Virginia	23230	Recruiting	Name: Phone:
Geolocation is 47.6105427, -122.142426	Bellevue	Washington	98007	Recruiting	Name: Phone:
Geolocation is 46.239409, -119.2934654	Richland	Washington	99352	Recruiting	Name: Phone:
Geolocation is 49.8847057, -119.4765266	Kelowna	British Columbia	V1Y 3G8	Recruiting	Name: Phone:
Geolocation is 44.2308656, -76.486077	Kingston	Ontario	K7L 5G2	Recruiting	Name: Phone:
Geolocation is 44.3073347, -78.3218108	Peterborough	Ontario	K9H 2P4	Recruiting	Name: Phone:
Geolocation is 43.698592, -79.4751345	Toronto	Ontario	M6M 3Z5	Recruiting	Name: Phone:
Geolocation is 43.7585342, -79.3535081	Toronto	Ontario	M3B 2S7	Recruiting	Name: Phone:
Geolocation is 50.4542964, -104.6381398	Regina	Saskatchewan	S4T 1A5	Recruiting	Name: Phone:

Agency
Elan Pharmaceuticals

Agency
Elan Pharmaceuticals

Facility Investigators:

Study Contact:

Name	Phone
Barbara Gaunce	910-558-4645

Locations

ClinicalTrials.gov ID

NCT01735630 (follow link to view full record on ct.gov in new window)

Official Title:

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Efficacy and Safety Study of Oral ELND005 for Treatment of Agitation and Aggression in Patients With Moderate to Severe Alzheimer's Disease

Study Start Date:

November 2012

Study End Date:

December 2013

Disease Stage:

Early

Middle

Late

Enrollment:

400

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ELND005 for Agitation and Aggression in Alzheimer's Disease

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ELND005 for Agitation and Aggression in Alzheimer's Disease

ELND005 for Agitation and Aggression in Alzheimer's Disease