Memory Disorders, Age-RelatedPhase 4NCT00276510
A Study of EGb 761® (Tanakan®) in Dementia of Alzheimer Type Onset in Patients Suffering From Memory Complaints
A Phase 4 study testing EGb 761® (Tanakan®) in people with Memory Disorders, Age-Related and Retention Disorders, Cognitive, run by Ipsen at 698 sites in France.
Trial summary
The purpose of this study is to determine whether Tanakan® is effective at slowing the progression from memory complaint to dementia of Alzheimer's type. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Memory Disorders, Age-Related, Retention Disorders, Cognitive
- What is being tested?
- EGb 761® (Tanakan®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,878 participants
- Where
- 698 sitesFrance
- Study dates
- Feb 2002to Nov 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Spontaneously reporting a memory complaint
- Short anxiety battery test < 6, (only if patient screened at GP site)
- Geriatric depression scale < 15
- Mini-mental state (MMS) > 25 in GP's office (in hospital site MMS is done as complementary scale)
Who cannot join
- Objective memory impairment
- Clinician rated dementia staging system > 0.5
- Mini-mental state < 25
- Dementia, past history of seizures, Parkinson disease
Trial locations and contacts
698 sites in 1 country.
300 sites in 1 country
France300 sites
1 rue de l'Orient
Agde, 34300
3 Avenue de Marlioz
Aix-les-Bains, 73100
3 rue Auguste Delaune
Alès, 30100
17 rue du Cardinal Georges d'Amboise
Amboise, 37400
17 rue Manuel
Amboise, 37400
83 rue Nicolas et Paul Paquet
Ancerville, 55170
10 bd De La Republique
Andernos-les-Bains, 33510
107 bd De La Republique
Andernos-les-Bains, 33510
19 rue Jean Saccheti
Andernos-les-Bains, 33510
128 Rue Bressigny
Angers, 49000
18 rue Martin Luther King
Angers, 49000
2 boulevard Jacques Millot
Angers, 49000
21 bd Roi René
Angers, 49000
25, rue St Nicolas
Angers, 49000
59 Boulevard Joseph Bédier
Angers, 49000
61 Ave Jean XXIII
Angers, 49000
68A rue d'Orgemont
Angers, 49000
Residence le Paradis Bat 17, 74-78 rue Volney
Angers, 49000
Centre Hospitalier Universitaire Hotel Dieu Gerontologie Clinique 4 rue Larrey
Angers, 49033
111 rue de la Chalouère
Angers, 49100
4 rue Saint Jacques
Angers, 49100
4, rue St Jacques
Angers, 49100
7 rue Thiers
Angers, 49100
1172 route de Grasse Ste Elisabeth
Antibes, 06600
20 boulevard Albert 1er
Antibes, 06600
700 av. Jules Grec
Antibes, 06600
26 R Pres Wilson
Ars-sur-Moselle, 57130
Avenue Joseph Lafont
Aubagne, 13400
Groupe Piettot Bâtiment 2
Aubagne, 13400
37-39 boulevard Anatole France
Aubervilliers, 93300
26 av. Charles de Gaulle
Aubevoye, 27940
3 Avenue de Verdun
Audenge, 33980
27 rue Maréchal Foch
Aumetz, 57710
2 bis route de Miremont
Auterive, 31190
70 bis rue Etienne Billieres
Auterive, 31190
17 rue des Ecoles
Avoine, 37420
17, rue des Ecoles
Avoine, 37420
10 Allée Des Rochers
Avrillé, 49240
30 Ter Avenue Pierre Mendès
Avrillé, 49240
5 Place Maréchal Juin
Avrillé, 49240
Rd point de Gal de Gaulle
Avrillé, 49240
1 Résidence Marcel Paul
Bachant, 59138
11 rue du pont Fouchard
Bagneux, 49400
13, rue Denis Papin
Bagnolet, 93170
11 rue du Général Cheroutre
Bailleul, 59270
17 rue de la Croix de Pierre
Bain-de-Bretagne, 35470
9 av Pierre Coupeau
Balma, 31130
43 rue Ducs de Bar
Bar-le-Duc, 55000
33 rue Jean Jaures
Bassens, 33530
21, rue Georges Clémenceau
Baugé, 49180
24, rue Julien Daillière
Bauné, 49140
Centre Commercial Tertifume 9 rue de Montreuil
Beaucouzé, 49070
42 rue de la Petite Porte
Beaufort-en-Vallée, 49250
14 rue Moulin du Roy
Beaulieu-sur-Layon, 49750
L'Helvetia 10 rue Paul Doumer
Beaulieu-sur-Mer, 06310
31, rue du Parc
Beaumont-en-Véron, 37420
Rue Lapeyrère
Beaumont-sur-Lèze, 31870
2 r Des Muriers
Beauzelle, 31700
Route de Toulouse
Bérat, 31370
24bis, rue de la Motte
Bersée, 59235
1 Avenue Gambetta
Béziers, 34500
1, rue du Pinot
Béziers, 34500
Centre Médical Sémard 39, place Semard
Béziers, 34500
9 bis Chemin Aussonne
Blagnac, 31700
208 Cours Saint Louis
Bordeaux, 33000
28 bd Du President Wilson
Bordeaux, 33000
8, Boulevard Albert 1er
Bordeaux, 33000
Centre Hospitalier Pellegrin-Tripode Service de Neurologie Place Amelie Raba-Leon
Bordeaux, 33076
Résidence Mozart- Apt 56, 2 rue Jean Artus
Bordeaux, 33300
183 Cours De La Marne
Bordeaux, 33800
Les Suriaux Rue du Stade
Boucé, 61570
2 allée Port Larron
Bouchemaine, 49080
60 Rue Du Moulin
Bouguenais, 44340
1 Rue Roeckel
Bourg-la-Reine, 92340
12 Esplanade du Prado
Bourges, 18000
121 Avenue du Général de Gaulle
Bourges, 18000
14 rue Calvin
Bourges, 18000
16 rue Emile Martin
Bourges, 18000
24 Boulevard Clémenceau
Bourges, 18000
86 Avenue Haegelen
Bourges, 18000
Centre Hospitalier Jacques Coeur Hopital Taillegrain Centre de Gerontologie des Pres Fichaux 6 rue Taillegrain
Bourges, 18000
Centre Hospitalier Jacques Coeur Hôpital Taillegrain
Bourges, 18000
9, rue du Lavoir
Brain-sur-Allonnes, 49650
106, rue du Docteur Lahaye
Breteuil, 27180
30 rue de Bayeux
Bretteville-l'Orgueilleuse, 14740
1 rue mar Leclerc
Broglie, 27270
Avenue du Gal de Gaulle
Bruges, 33520
57 impasse des Cades
Cabrières, 30210
114, rue Authie
Caen, 14000
29 rue Lucien Nelle
Caen, 14000
36, Avenue Du 6 Juin
Caen, 14000
6 Avenue Du 6 Juin 1944
Caen, 14000
98 Boulevard du Maréchal Lyautey
Caen, 14000
Hopital Cote de Nacre Service de Neurologie avenue de la cote de Nacre
Caen, 14033
Hôpital Côte de Nacre
Caen, 14033
12 Grand Rue
Calmont, 31560
16, rue d'Alger
Cambrai, 59400
Square la Gare
Candé, 49440
Avenue Buchholz
Cantaleu, 76380
8 Boulevard Ronceray
Cantenay-Épinard, 49460
3 rue Lucien Cassagne
Carbonne, 31390
La Chohonniere Im. la Rotonde
Carquefou, 44470
10 avenue Victor Hugo
Cassis, 13160
4 route de Toulouse
Castelmaurou, 31180
2 rue Clairval
Castelnau-le-Lez, 34170
311 chemin Draye du Marbre
Castelnau-le-Lez, 34170
Avenue A Briand
Castelnau-le-Lez, 34170
Villa 54. Résidence le Village
Castelnau-le-Lez, 34170
Place d'Armes
Cazères, 31120
27 rue Emile Landais
Chacé, 49400
15 rue des Sables
Chalonnes-sur-Loire, 49290
8 rue Seguin
Château Gontier Bazouges, 53200
8 rue Sainte Croix
Châteaugiron, 35410
16 Bis rue Cherré
Châteauneuf-sur-Sarthe, 49330
48 rue Henri Bouriché
Chemellier, 49320
290 rue du Bocage
Cheux, 14210
11 rue du 11 Novembre 1945
Chinon, 37500
Place Pierre Robbe
Chinon, 37500
14 rue Faidherbe
Cholet, 49300
16 Av de l'Europe
Cholet, 49300
18, avenue des Calins
Cholet, 49300
25 av de Nantes
Cholet, 49300
43 Bis Rue Nationale
Cholet, 49300
6 Allée des forgerons
Cholet, 49300
83 Rue du Paradis
Cholet, 49300
55, rue Eugène Lecoq
Clary, 59225
7 rue du Docteur Doussain
Clisson, 44190
5 rue du Couderc
Colomiers, 31770
7 rue d'Auch
Colomiers, 31770
13 rue du Docteur Malabouche
Cournonterral, 34660
4 Bld Jean-Baptiste Oudry
Créteil, 94000
61 Rue de l'amiral Courbet
Croix, 59170
9 rue Peyrere
Cubzac-les-Ponts, 33240
14 rue du Cezerou
Cugnaux, 31270
14, rue Cézerou
Cugnaux, 31270
3 avenue de Toulouse
Cugnaux, 31270
6 place de Vivier
Cugnaux, 31270
2 rue Abbé Bernier
Daon, 53200
116 rue Henri Barbusse
Denain, 59220
221 rue Villars
Denain, 59220
25 place de I'Eglise
Déville-lès-Rouen, 76250
11 rue Principale
Diebling, 57980
1 Avenue Edouard VII
Dinard, 35800
10 rue Mathieu de Dombasle
Dombasle-sur-Meurthe, 54110
La Tour des Charmettes
Domène, 38420
18, rue Danton
Drancy, 93700
97, rue Winston Churchill
Dunkirk, 59240
Résidence Emeraude 71 av Adolphe Geeraert
Dunkirk, 59240
72 rue Saint Pierre
Durtal, 49430
2 rue Jean Monnet
Eaunes, 31600
108 Faubourg Ambrail
Épinal, 88000
4 rue du Général de Gaulle
Essey-lès-Nancy, 54270
3 Place de l'Eglise
Étalondes, 76260
1 rue du Jardin Botanique
Évreux, 27000
24, rue des Lombards
Évreux, 27000
41 rue Victor Hugo
Évreux, 27000
6 Centre Commercial les Peupliers
Évreux, 27000
Route Nationale 75
Eyguians, 05300
7 rue Pasteur
Fabrègues, 34690
3 route de Caen
Falaise, 14700
33 rue du Camp Fermé
Falaise, 14700
1 rue Renelles
Fécamp, 76400
2 rue de I'Eglise
Fenouillet, 31150
126 Route d'Harcourt
Fleury-sur-Orne, 14123
11 bis av. Ambroise Croisat
Fontaine, 38600
3 place Louis Maisonnat
Fontaine, 38610
1, rue Pierre et Marie Curie
Fontès, 34320
21 rue Nationale
Forbach, 57600
34 rue du Marechal Soult
Fresnes, 59970
2 pl Clemenceau
Fresnes-en-Woëvre, 55160
10, Rue Du 8 Mai
Fronton, 31620
10 route des Mares
Frossay, 44320
74 avenue de la Liberation
Frouard, 54390
2 avenue des Camelias
Gan, 64290
2 bis rue Abon
Gap, 05000
2 bis rue d'Abon
Gap, 05000
Residence Le Gaughin Bat 1 68 rue Borely
Gardanne, 13120
Villa Pinede Route St Tropez
Gassin, 83580
18, avenue de Verdun
Gémenos, 13420
24, rue de la République
Gémenos, 13420
12 rue Cohue
Gennes, 49350
10 rue de la Sèvre
Gétigné, 44190
18 r Stade
Gironde-sur-Dropt, 33190
4 ave de la Gare
Gourdan-Polignan, 31210
Centre Commercial Malartic
Gradignan, 33170
41, rue Saint-Yves
Grand-Champ, 56390
12, Place Jean Moulin
Grenoble, 38000
13 bis rue du General Champon
Grenoble, 38000
15, chemin Joseph Brun
Grenoble, 38000
22 av. Leon Blum
Grenoble, 38000
28 rue Elie Cartan
Grenoble, 38000
35 Bd Marechal Foch
Grenoble, 38000
46 boulevard Joseph Vallier
Grenoble, 38000
6, Boulevard Joseph Vallier
Grenoble, 38000
9A place Saint-Bruno
Grenoble, 38000
Centre de Prevention des Alpes 3 place de Metz
Grenoble, 38000
15, chemin Joseph Brun
Grenoble, 38100
28 rue Général Ferrié
Grenoble, 38100
32 rue Gay-Lussac
Grenoble, 38100
34 avenue de l'Europe Immeuble le Trident A1er etage
Grenoble, 38100
4 avenue de la Bouexiere
Guérande, 44350
117 cours de Verdun
Gujan-Mestras, 33470
117, avenue du Maréchal de Lattre de Tassigny
Gujan-Mestras, 33470
6 pl Du Marché - La Hume
Gujan-Mestras, 33470
14 rue de la Liberation
Halluin, 59250
14 rue Libération
Halluin, 59250
3, rue Paul Vaillant Couturier
Haulchin, 59121
12 rue de Maubeuge
Hautmont, 59330
206 rue Gambetta
Hautmont, 59330
1 rue Franz Schubert Saint Martin d'Hères
Hères, 38400
136 av. Ambroise Croizat Saint Martin d'Heres
Hères, 38400
20 av. Paul Eluard
Hères, 38400
137 Route de Dax
Hinx, 40180
2 bis, route de Belin
Hostens, 33125
5 rue Mairie
Ingrandes, 49123
10 rue Gaston Monmousseau
Ivry-sur-Seine, 94200
Hopital Charles Foix Service de Gerontologie 37 avenue de la Republique
Ivry-sur-Seine, 94205
119 rue Franchepre
Jœuf, 54240
6 rue des Ponts
Jort, 14170
20 avenue de l'Amiral Courbet
Juan-les-Pins, 06150
117 Boulevard du Président Wilson
Juan-les-Pins, 06160
4 Chemin du Tanit
Juan-les-Pins, 06160
Le Tanagra- 10 pl du Pont du Lys
Juan-les-Pins, 06160
7 Route de Gagnebert
Juigné sur Loire, 49610
2 rue Roger Salengro
L'Haÿ-les-Roses, 94240
76, avenue Gabriel Péri
L'Haÿ-les-Roses, 94240
Le Moulin
La Bâtie-Neuve, 05230
33 rue Georges Clemenceau
La Bernerie-en-Retz, 44760
La buffaie Route du Doreur
La Breille-les-Pins, 49390
Avenue du Général de Gaulle
La Calmette, 30190
Maison Médicale av. Géneral de Gaulle
La Calmette, 30190
53 rue Martin Luther King
La Chapelle, 44240
4 rue Meriadec Laennec
La Chapelle-Basse-Mer, 44450
4 rue Mériadec Laënnec
La Chapelle-Basse-Mer, 44450
10 rue Aristide Briand
La Chapelle-Heulin, 44330
17 rue de l'Erdre
La Chapelle-sur-Erdre, 44240
53 rue Martin Luther King
La Chapelle-sur-Erdre, 44240
10 , rue Adolphe Abeille
La Ciotat, 13600
62, ru du Maréchal de Lattre de Tass
La Forêt-sur-Sèvre, 79380
8 Chemin des Vendéens
La Jubaudière, 49510
149 route de Bouguenais
La Montagne, 44620
9 av. de la Liberation
La Montagne, 44620
9 rue de la Liberation
La Montagne, 44620
Village Retraite
La Motte-du-Caire, 04250
4 route de Balaruc
La Peyrade, 34110
11 Place Sainte Anne
La Riche, 37520
7 route Targon
La Sauve, 33670
1 rue Joffre
La Teste-de-Buch, 33260
4 place de la République
La Trinité, 06340
16 Grand'rue
La Tronche, 38700
24 boulevard de la Chantourne
La Tronche, 38700
8 Place Vincent Auriol
Labarthe-sur-Lèze, 31860
4, chemin Banque
Labastidette, 31600
34, rue Vacheresse
Lagny-sur-Marne, 77400
23 rue Pasteur
Laragne, 05300
52 Place de la Fontaine
Laragne, 05300
23 avenue Pasteur
Laragne-Montéglin, 05300
23 rue Louis Pasteur
Laragne-Montéglin, 05300
43 rue Raymond Poincaré
Laxou, 54520
44 bis rue Paul Bert
Laxou, 54520
44b rue Paul Bert
Laxou, 54520
49 r Theophile Gautier
Le Bouscat, 33110
5 Av. Gauthier Lagardère
Le Bouscat, 33110
26 Avenue Jean Macé
Le Cailar, 30740
8 Avenue Louis Blanc
Le Cailar, 30740
6 rue Colbert
Le Canet, 06110
1 rue des Orangers
Le Cannet, 06110
50 Bd Sadi Carnot
Le Cannet, 06110
69 av. F. Roosevelt
Le Cannet, 06110
Route de Marignac
Le Fousseret, 31430
7 place du Commerce
Le Fuilet, 49270
17 rue du Dr Leveillé
Le Grand-Pressigny, 37350
35 Avenue du Président Kennedy
Le Grand-Quevilly, 76120
60 rue des Moussaillons
Le Grau-du-Roi, 30240
1 Quai de Bretagne
Le Lion-dAngers, 49220
1 rue Pasteur
Le May, 49122
48 rue des Mauges
Le Mesnil-en-Vallée, 49410
111 route de Paris
Le Mesnil-Esnard, 76240
Impasse Mérite, Résidence Lamiot rue L'ecalier
Le Neubourg, 27110
31 rue Promenade
Le Puy-Saint-Bonnet, 49300
21 rue de Nantes
Le Temple-de-Bretagne, 44360
364 rue Pasteur
Le Versoud, 38420
23 rue Jeanne d'Arc
Les Epesses, 85590
46 rue de Paris
Les Lilas, 93260
2 rue des Pleiades
Les Mureaux, 78130
8 Avenue Amiral Chauvin
Les Ponts-de-Cé, 49130
68 ter Rue Marjolin
Levallois-Perret, 92300
11 place de l'Eglise
Lherm, 31600
34 avenue Georges Clémenceau
Libourne, 33500
46 avenue François Mitterand
Liffré, 35340
110 BD de la liberté
Lille, 59000
115 bis rue d'Artois
Lille, 59000
129 Rue Des Postes
Lille, 59000
19 Rue Des Postes
Lille, 59000
236 rue du Faubourg des Postes
Lille, 59000
24 rue P. Legrand
Lille, 59000
Hopital Roger Salengro Service de Neurologie C rue Emile Laine
Lille, 59037
Hôpital Roger Salengro
Lille, 59037
Parc du Segrais
Lognes, 77185
928 avenue de Dunkerque
Lomme, 59160
About this study
Official title: Efficacy and Tolerance of EGb 761® 120mg Two Times a Day on Dementia of Alzheimer Type's Onset in Patients Suffering From Memory Complaints. A Randomised, Double-blind, Multicentre, Parallel Groups, Placebo Controlled Phase IIIb/IV Study in Elderly Over 70
The purpose of this study is to determine whether Tanakan® is effective at slowing the progression from memory complaint to dementia of Alzheimer's type.
- Being tested
- EGb 761® (Tanakan®), Placebo
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGb 761® (Tanakan®)Drug
120 mg, 1 tablet twice a day, oral route, during 5 years.
PlaceboOther
1 tablet twice a day, oral route, during 5 years.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: EGb 761® (Tanakan®) |
| 2 | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
EGb 761® efficacy on conversion rate of memory complaint to dementia of Alzheimer type by a survival analysis
Measured: Baseline, month 12, 24, 36, 48 and 60
Secondary outcomes (5)
Efficacy on rate of cognitive abilities decline
Measured: Baseline, month 12, 24, 36, 48 and 60
Effect on concomitant diseases
Measured: Baseline, month 12, 24, 36, 48 and 60
Concomitant treatments' reports
Measured: Baseline, month 12, 24, 36, 48 and 60
Global evaluation of memory complaint by the patient
Measured: Baseline, month 12, 24, 36, 48 and 60
Clinical safety
Measured: Baseline, month 12, 24, 36, 48 and 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startFeb 2002
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Memory Disorders, Age-RelatedStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,878 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276510
- Sponsor's protocol ID
- 2-31-00240-011
- Status last verified
- Jan 2019
- First submitted
- 12 Jan 2006
- Last updated
- 15 Jan 2019
- Results posted
- No
Publications
Vellas B, Coley N, Ousset PJ, Berrut G, Dartigues JF, Dubois B, Grandjean H, Pasquier F, Piette F, Robert P, Touchon J, Garnier P, Mathiex-Fortunet H, Andrieu S; GuidAge Study Group. Long-term use of standardised Ginkgo biloba extract for the prevention of Alzheimer's disease (GuidAge): a randomised placebo-controlled trial. Lancet Neurol. 2012 Oct;11(10):851-9. doi: 10.1016/S1474-4422(12)70206-5. Epub 2012 Sep 6.
PubMed 22959217
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerance of EGb 761® 120mg Two Times a Day on Dementia of Alzheimer Type's Onset in Patients Suffering From Memory Complaints. A Randomised, Double-blind, Multicentre, Parallel Groups, Placebo Controlled Phase IIIb/IV Study in Elderly Over 70
- ClinicalTrials.gov ID
- NCT00276510
- Acronym / sponsor ID
- 2-31-00240-011
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,878 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Feb 2002
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 13 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Tanakan® is effective at slowing the progression from memory complaint to dementia of Alzheimer's type.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: EGb 761® (Tanakan®) |
| 2 | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Spontaneously reporting a memory complaint
- Short anxiety battery test < 6, (only if patient screened at GP site)
- Geriatric depression scale < 15
- Mini-mental state (MMS) > 25 in GP's office (in hospital site MMS is done as complementary scale)
Key exclusion criteria (4 listed)
- Objective memory impairment
- Clinician rated dementia staging system > 0.5
- Mini-mental state < 25
- Dementia, past history of seizures, Parkinson disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EGb 761® (Tanakan®)120 mg, 1 tablet twice a day, oral route, during 5 years. | Drug | 1 |
| Placebo1 tablet twice a day, oral route, during 5 years. | Other | 2 |
Primary outcome
EGb 761® efficacy on conversion rate of memory complaint to dementia of Alzheimer type by a survival analysis
Time frame: Baseline, month 12, 24, 36, 48 and 60
5 secondary outcomes
Efficacy on rate of cognitive abilities decline
Time frame: Baseline, month 12, 24, 36, 48 and 60
Effect on concomitant diseases
Time frame: Baseline, month 12, 24, 36, 48 and 60
Concomitant treatments' reports
Time frame: Baseline, month 12, 24, 36, 48 and 60
Global evaluation of memory complaint by the patient
Time frame: Baseline, month 12, 24, 36, 48 and 60
Clinical safety
Time frame: Baseline, month 12, 24, 36, 48 and 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Derived from this study: PubMed 22959217Vellas B, Coley N, Ousset PJ, Berrut G, Dartigues JF, Dubois B, Grandjean H, Pasquier F, Piette F, Robert P, Touchon J, Garnier P, Mathiex-Fortunet H, Andrieu S; GuidAge Study Group. Long-term use of standardised Ginkgo biloba extract for the prevention of Alzheimer's disease (GuidAge): a randomised placebo-controlled trial. Lancet Neurol. 2012 Oct;11(10):851-9. doi: 10.1016/S1474-4422(12)70206-5. Epub 2012 Sep 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
698 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EGb 761® (Tanakan®) in people with Memory Disorders, Age-Related and Retention Disorders, Cognitive, run by Ipsen at 698 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 698 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EGb 761® efficacy on conversion rate of memory complaint to dementia of Alzheimer type by a survival analysis (time frame: Baseline, month 12, 24, 36, 48 and 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00276510, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.